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CarboClear Pedicle Screw System

Model Navigated Probe - Blunt, Straight · CARBOFIX ORTHOPEDICS LTD · DI 07290110208400

NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23562019-01: 0 reports for this device; peer average 2.44/device2019-02: 0 reports for this device; peer average 2.99/device2019-03: 0 reports for this device; peer average 2.7/device2019-04: 0 reports for this device; peer average 2.53/device2019-05: 0 reports for this device; peer average 2.82/device2019-06: 0 reports for this device; peer average 2.68/device2019-07: 0 reports for this device; peer average 2.46/device2019-08: 0 reports for this device; peer average 2.96/device2019-09: 0 reports for this device; peer average 2.44/device2019-10: 0 reports for this device; peer average 2.98/device2019-11: 0 reports for this device; peer average 4.08/device2019-12: 0 reports for this device; peer average 2.58/device2020-01: 0 reports for this device; peer average 2.99/device2020-02: 0 reports for this device; peer average 3.65/device2020-03: 0 reports for this device; peer average 3.38/device2020-04: 0 reports for this device; peer average 5.03/device2020-05: 0 reports for this device; peer average 2.58/device2020-06: 0 reports for this device; peer average 2.54/device2020-07: 0 reports for this device; peer average 2.99/device2020-08: 0 reports for this device; peer average 2.37/device2020-09: 0 reports for this device; peer average 3.18/device2020-10: 0 reports for this device; peer average 4.47/device2020-11: 0 reports for this device; peer average 3.87/device2020-12: 0 reports for this device; peer average 3.1/device2021-01: 0 reports for this device; peer average 3.7/device2021-02: 0 reports for this device; peer average 3.07/device2021-03: 0 reports for this device; peer average 3.24/device2021-04: 0 reports for this device; peer average 3.14/device2021-05: 0 reports for this device; peer average 3.26/device2021-06: 0 reports for this device; peer average 3.21/device2021-07: 0 reports for this device; peer average 2.83/device2021-08: 0 reports for this device; peer average 2.43/device2021-09: 0 reports for this device; peer average 2.39/device2021-10: 0 reports for this device; peer average 2.4/device2021-11: 0 reports for this device; peer average 3.09/device2021-12: 0 reports for this device; peer average 2.63/device2022-01: 0 reports for this device; peer average 2.38/device2022-02: 0 reports for this device; peer average 2.64/device2022-03: 0 reports for this device; peer average 2.63/device2022-04: 0 reports for this device; peer average 2.33/device2022-05: 0 reports for this device; peer average 3.13/device2022-06: 0 reports for this device; peer average 3.39/device2022-07: 0 reports for this device; peer average 4.19/device2022-08: 0 reports for this device; peer average 2.38/device2022-09: 0 reports for this device; peer average 2.51/device2022-10: 0 reports for this device; peer average 2.8/device2022-11: 0 reports for this device; peer average 2.7/device2022-12: 0 reports for this device; peer average 3.27/device2023-01: 0 reports for this device; peer average 2.69/device2023-02: 0 reports for this device; peer average 2.78/device2023-03: 0 reports for this device; peer average 2.83/device2023-04: 0 reports for this device; peer average 2.63/device2023-05: 0 reports for this device; peer average 2.35/device2023-06: 0 reports for this device; peer average 2.18/device2023-07: 0 reports for this device; peer average 2.43/device2023-08: 0 reports for this device; peer average 2.39/device2023-09: 0 reports for this device; peer average 3.45/device2023-10: 0 reports for this device; peer average 3/device2023-11: 0 reports for this device; peer average 6.39/device2023-12: 0 reports for this device; peer average 3.29/device2024-01: 0 reports for this device; peer average 2.82/device2024-02: 0 reports for this device; peer average 3.39/device2024-03: 0 reports for this device; peer average 3.86/device2024-04: 0 reports for this device; peer average 2.83/device2024-05: 0 reports for this device; peer average 4.3/device2024-06: 0 reports for this device; peer average 3.86/device2024-07: 0 reports for this device; peer average 3.11/device2024-08: 0 reports for this device; peer average 3.35/device2024-09: 0 reports for this device; peer average 4.15/device2024-10: 0 reports for this device; peer average 4.6/device2024-11: 0 reports for this device; peer average 3.68/device2024-12: 0 reports for this device; peer average 3.19/device2025-01: 0 reports for this device; peer average 6.07/device2025-02: 0 reports for this device; peer average 3.65/device2025-03: 0 reports for this device; peer average 3.1/device2025-04: 0 reports for this device; peer average 3.42/device2025-05: 0 reports for this device; peer average 3.72/device2025-06: 0 reports for this device; peer average 3.46/device2025-07: 0 reports for this device; peer average 3.36/device2025-08: 0 reports for this device; peer average 4.01/device2025-09: 0 reports for this device; peer average 3.03/device2025-10: 0 reports for this device; peer average 3.33/device2025-11: 0 reports for this device; peer average 3.32/device2025-12: 0 reports for this device; peer average 3.95/device2026-01: 0 reports for this device; peer average 3.61/device2026-02: 0 reports for this device; peer average 3.43/device2026-03: 0 reports for this device; peer average 3.38/device2026-04: 0 reports for this device; peer average 3.2/device2026-05: 0 reports for this device; peer average 4.02/device2026-06: 0 reports for this device; peer average 3.93/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.44
2019-0202.99
2019-0302.7
2019-0402.53
2019-0502.82
2019-0602.68
2019-0702.46
2019-0802.96
2019-0902.44
2019-1002.98
2019-1104.08
2019-1202.58
2020-0102.99
2020-0203.65
2020-0303.38
2020-0405.03
2020-0502.58
2020-0602.54
2020-0702.99
2020-0802.37
2020-0903.18
2020-1004.47
2020-1103.87
2020-1203.1
2021-0103.7
2021-0203.07
2021-0303.24
2021-0403.14
2021-0503.26
2021-0603.21
2021-0702.83
2021-0802.43
2021-0902.39
2021-1002.4
2021-1103.09
2021-1202.63
2022-0102.38
2022-0202.64
2022-0302.63
2022-0402.33
2022-0503.13
2022-0603.39
2022-0704.19
2022-0802.38
2022-0902.51
2022-1002.8
2022-1102.7
2022-1203.27
2023-0102.69
2023-0202.78
2023-0302.83
2023-0402.63
2023-0502.35
2023-0602.18
2023-0702.43
2023-0802.39
2023-0903.45
2023-1003
2023-1106.39
2023-1203.29
2024-0102.82
2024-0203.39
2024-0303.86
2024-0402.83
2024-0504.3
2024-0603.86
2024-0703.11
2024-0803.35
2024-0904.15
2024-1004.6
2024-1103.68
2024-1203.19
2025-0106.07
2025-0203.65
2025-0303.1
2025-0403.42
2025-0503.72
2025-0603.46
2025-0703.36
2025-0804.01
2025-0903.03
2025-1003.33
2025-1103.32
2025-1203.95
2026-0103.61
2026-0203.43
2026-0303.38
2026-0403.2
2026-0504.02
2026-0603.93
This device (reports/month)Average device in NKB, OLO (reports/device/month)

Regulatory clearances

  • K201251 SESE 2020-08-05 (k number procode)

Predicate lineage

K201251 — cites (transitively): K124004 (d1), K140454 (d1), K143375 (d1), K153203 (d1), K153442 (d1), K173487 (d1), K182377 (d1), K050438 (d2), K091974 (d2), K102555 (d2), K113529 (d2), K132639 (d2), K141605 (d2), K142847 (d2), K143628 (d2), K050439 (d2), K111520 (d2), K113174 (d2), K121020 (d2), K150231 (d2), K152457 (d2), K052398 (d2), K152604 (d2), K160879 (d2), K170347 (d2), K170543 (d2), K130291 (d2), K981676 (d2), K061113 (d3), K061639 (d3), K063305 (d3), K081475 (d3), K102701 (d3), K111571 (d3), K033901 (d3), K062085 (d3), K063156 (d3), K073126 (d3), K073364 (d3), K052747 (d3), K122862 (d3), K141494 (d3), K131425 (d3), K142591 (d3), K042025 (d3), K150460 (d3), K113164 (d3), K162912 (d3), K090648 (d4), K011182 (d4), K070387 (d4), K073562 (d4), K080313 (d4), K102249 (d4), K063736 (d4), K073291 (d4), K083026 (d4), K103731 (d4), K112405 (d4), K140276 (d4), K031655 (d4), K052187 (d4), K093828 (d4), K102397 (d4), K160904 (d4), K033801 (d5), K041584 (d5), K062174 (d5), K091445 (d5), K111457 (d5), K132328 (d5), K132471 (d5), K103490 (d5), K110216 (d5), K111136 (d5), K130877 (d5), K131802 (d5), K955348 (d6), K063741 (d6), K101993 (d6), K090390 (d6), K101074 (d6), K040962 (d7), K050981 (d7) — cited as predicate by K210716

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — CARBOFIX ORTHOPEDICS LTD

  • VAI 2017-03-02 CarboFix Orthopedics, Ltd. · 4 citations
  • VAI 2017-03-02 CarboFix Orthopedics, Ltd. · 4 citations