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VYRSA V1

Model VYV1-103-121-04 · Vyrsa Technologies · DI G418VYV1103121040

LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540

OUR — Sacroiliac Joint Fixation · Class II · 21 CFR 888.3040

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.

13452019-01: 0 reports for this device; peer average 2.45/device2019-02: 0 reports for this device; peer average 2.29/device2019-03: 0 reports for this device; peer average 2.25/device2019-04: 0 reports for this device; peer average 2.09/device2019-05: 0 reports for this device; peer average 2.2/device2019-06: 0 reports for this device; peer average 2.28/device2019-07: 0 reports for this device; peer average 2.34/device2019-08: 0 reports for this device; peer average 2.24/device2019-09: 0 reports for this device; peer average 2.66/device2019-10: 0 reports for this device; peer average 2.12/device2019-11: 0 reports for this device; peer average 2.08/device2019-12: 0 reports for this device; peer average 2.27/device2020-01: 0 reports for this device; peer average 2.34/device2020-02: 0 reports for this device; peer average 2.13/device2020-03: 0 reports for this device; peer average 2.12/device2020-04: 0 reports for this device; peer average 2.23/device2020-05: 0 reports for this device; peer average 2.11/device2020-06: 0 reports for this device; peer average 2.63/device2020-07: 0 reports for this device; peer average 3.61/device2020-08: 0 reports for this device; peer average 3.3/device2020-09: 0 reports for this device; peer average 3.48/device2020-10: 0 reports for this device; peer average 3.97/device2020-11: 0 reports for this device; peer average 3.57/device2020-12: 0 reports for this device; peer average 3.51/device2021-01: 0 reports for this device; peer average 3.6/device2021-02: 0 reports for this device; peer average 3.63/device2021-03: 0 reports for this device; peer average 3.2/device2021-04: 0 reports for this device; peer average 3.4/device2021-05: 0 reports for this device; peer average 3.15/device2021-06: 0 reports for this device; peer average 2.97/device2021-07: 0 reports for this device; peer average 2.64/device2021-08: 0 reports for this device; peer average 3.24/device2021-09: 0 reports for this device; peer average 2.77/device2021-10: 0 reports for this device; peer average 2.47/device2021-11: 0 reports for this device; peer average 3.06/device2021-12: 0 reports for this device; peer average 2.65/device2022-01: 0 reports for this device; peer average 2.58/device2022-02: 0 reports for this device; peer average 3.13/device2022-03: 0 reports for this device; peer average 3.17/device2022-04: 0 reports for this device; peer average 3.51/device2022-05: 0 reports for this device; peer average 3.7/device2022-06: 0 reports for this device; peer average 2.82/device2022-07: 0 reports for this device; peer average 2.48/device2022-08: 0 reports for this device; peer average 2.6/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.08/device2022-11: 0 reports for this device; peer average 3.6/device2022-12: 0 reports for this device; peer average 3.73/device2023-01: 0 reports for this device; peer average 4.57/device2023-02: 0 reports for this device; peer average 3.11/device2023-03: 0 reports for this device; peer average 3.63/device2023-04: 0 reports for this device; peer average 3.07/device2023-05: 0 reports for this device; peer average 3.19/device2023-06: 0 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.84/device2023-08: 0 reports for this device; peer average 2.87/device2023-09: 0 reports for this device; peer average 2.22/device2023-10: 0 reports for this device; peer average 2.4/device2023-11: 0 reports for this device; peer average 3.21/device2023-12: 0 reports for this device; peer average 3.04/device2024-01: 0 reports for this device; peer average 2.84/device2024-02: 0 reports for this device; peer average 3.01/device2024-03: 0 reports for this device; peer average 2.78/device2024-04: 0 reports for this device; peer average 3.58/device2024-05: 0 reports for this device; peer average 3.55/device2024-06: 0 reports for this device; peer average 3.68/device2024-07: 0 reports for this device; peer average 2.83/device2024-08: 0 reports for this device; peer average 2.71/device2024-09: 0 reports for this device; peer average 3.06/device2024-10: 0 reports for this device; peer average 3.09/device2024-11: 0 reports for this device; peer average 2.8/device2024-12: 0 reports for this device; peer average 2.55/device2025-01: 0 reports for this device; peer average 2.85/device2025-02: 0 reports for this device; peer average 4.24/device2025-03: 0 reports for this device; peer average 5.03/device2025-04: 0 reports for this device; peer average 2.79/device2025-05: 0 reports for this device; peer average 2.84/device2025-06: 0 reports for this device; peer average 2.76/device2025-07: 0 reports for this device; peer average 2.55/device2025-08: 0 reports for this device; peer average 2.6/device2025-09: 0 reports for this device; peer average 2.14/device2025-10: 0 reports for this device; peer average 2.36/device2025-11: 0 reports for this device; peer average 2.65/device2025-12: 0 reports for this device; peer average 3.79/device2026-01: 0 reports for this device; peer average 3.53/device2026-02: 0 reports for this device; peer average 3.45/device2026-03: 0 reports for this device; peer average 3.2/device2026-04: 0 reports for this device; peer average 3.11/device2026-05: 0 reports for this device; peer average 2.6/device2026-06: 0 reports for this device; peer average 3.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.45
2019-0202.29
2019-0302.25
2019-0402.09
2019-0502.2
2019-0602.28
2019-0702.34
2019-0802.24
2019-0902.66
2019-1002.12
2019-1102.08
2019-1202.27
2020-0102.34
2020-0202.13
2020-0302.12
2020-0402.23
2020-0502.11
2020-0602.63
2020-0703.61
2020-0803.3
2020-0903.48
2020-1003.97
2020-1103.57
2020-1203.51
2021-0103.6
2021-0203.63
2021-0303.2
2021-0403.4
2021-0503.15
2021-0602.97
2021-0702.64
2021-0803.24
2021-0902.77
2021-1002.47
2021-1103.06
2021-1202.65
2022-0102.58
2022-0203.13
2022-0303.17
2022-0403.51
2022-0503.7
2022-0602.82
2022-0702.48
2022-0802.6
2022-0902.82
2022-1003.08
2022-1103.6
2022-1203.73
2023-0104.57
2023-0203.11
2023-0303.63
2023-0403.07
2023-0503.19
2023-0603.19
2023-0702.84
2023-0802.87
2023-0902.22
2023-1002.4
2023-1103.21
2023-1203.04
2024-0102.84
2024-0203.01
2024-0302.78
2024-0403.58
2024-0503.55
2024-0603.68
2024-0702.83
2024-0802.71
2024-0903.06
2024-1003.09
2024-1102.8
2024-1202.55
2025-0102.85
2025-0204.24
2025-0305.03
2025-0402.79
2025-0502.84
2025-0602.76
2025-0702.55
2025-0802.6
2025-0902.14
2025-1002.36
2025-1102.65
2025-1203.79
2026-0103.53
2026-0203.45
2026-0303.2
2026-0403.11
2026-0502.6
2026-0603.35
This device (reports/month)Average device in LXH, OUR (reports/device/month)

Regulatory clearances

  • K233972 SESE 2024-02-27 (k number procode)
  • K203503 SESE 2022-09-02 (k number procode)

Predicate lineage

K203503 — cites (transitively): K173234 (d1), K173432 (d1), K180818 (d1), K012445 (d2), K021932 (d2), K110472 (d2), K131405 (d2), K161210 (d2), K051296 (d3), K080398 (d3), K092375 (d3), K102903 (d3), K110838 (d3), K914004 (d3), K123850 (d3), K111520 (d3), K124004 (d3), K140454 (d3), K150231 (d3), K061113 (d4), K061639 (d4), K063305 (d4), K081475 (d4), K122074 (d4), K050438 (d4), K131425 (d4), K073291 (d5), K083026 (d5), K103731 (d5), K112405 (d5) — cited as predicate by K233972

K233972 — cites (transitively): K161210 (d1), K203503 (d1), K110472 (d2), K111520 (d2), K124004 (d2), K131405 (d2), K140454 (d2), K150231 (d2), K173234 (d2), K173432 (d2), K180818 (d2), K021932 (d3), K051296 (d3), K080398 (d3), K092375 (d3), K102903 (d3), K110838 (d3), K914004 (d3), K061113 (d3), K061639 (d3), K063305 (d3), K081475 (d3), K050438 (d3), K123850 (d3), K131425 (d3), K012445 (d3), K122074 (d4), K073291 (d4), K083026 (d4), K103731 (d4), K112405 (d4) — cited as predicate by K250247

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

Manufacturer compliance record — Vyrsa Technologies

Nothing in the loaded window.