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3D-CUT

Model AR-13400PSG · 3D-Side · DI 05400550150654

PBF — Orthopaedic Surgical Planning And Instrument Guides · Class II · 21 CFR 888.3030

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.

12342019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device1112010709040506030607111205100508100811120304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1101
2019-1203
2020-0104
2020-0701
2020-0902
2021-0401
2021-0501
2021-0601
2022-0302
2022-0601
2022-0702.67
2022-1101
2022-1201
2023-0501
2023-1001
2024-0501
2024-0801
2024-1001
2025-0802
2025-1101
2025-1201
2026-0301
2026-0401
This device (reports/month)Average device in PBF (reports/device/month)

Regulatory clearances

  • K212237 SESE 2021-11-29 (k number procode)

Predicate lineage

K212237 — cites (transitively): K190044 (d1), K192979 (d1), K193614 (d1), K073468 (d2), K153482 (d2), K161634 (d2), K163579 (d2), K181241 (d2), K182789 (d2), K014155 (d2), K023941 (d2), K081353 (d2), K132290 (d2), K183011 (d2), K191996 (d2), K112389 (d3), K032413 (d3), K070169 (d3), K122860 (d3), K142823 (d3), K052424 (d3), K111641 (d3), K032442 (d3), K062570 (d3), K854886 (d3), K943347 (d3), K971297 (d3), K120956 (d3), K153207 (d3), K162674 (d3), K163593 (d3), K170214 (d3), K180239 (d3), K033363 (d3), K163700 (d3), K181302 (d3), K191150 (d3), K073449 (d4), K060950 (d4), K970617 (d4), K051165 (d4), K093772 (d4), K121302 (d4), K133616 (d4), K130185 (d4), K131360 (d4), K001945 (d4), K013248 (d4), K061808 (d4), K063672 (d4), K072740 (d4), K073460 (d4), K082807 (d4), K083213 (d4), K090675 (d4), K090692 (d4), K091479 (d4), K092812 (d4), K100776 (d4), K110908 (d4), K111678 (d4), K120359 (d4), K121651 (d4), K123000 (d4), K132510 (d4), K140376 (d4), K141784 (d4), K141992 (d4), K142581 (d4), K922500 (d4), K120157 (d4), K131061 (d4), K131445 (d4), K160264 (d4), K043570 (d4), K081351 (d4), K082358 (d4), K102069 (d4), K123380 (d4), K132640 (d4), K132788 (d4), K133811 (d4), K153418 (d4), K140397 (d4), K020602 (d5), K072832 (d5), K080522 (d5), K063049 (d5), K090063 (d5), K061011 (d5), K912735 (d5), K043059 (d5), K060746 (d5), K070031 (d5), K082320 (d5), K963118 (d5), K101962 (d5), K111041 (d5), K102429 (d5), K091614 (d5), K094037 (d5), K100502 (d5), K102282 (d5), K082081 (d5), K092670 (d5), K103705 (d5), K121277 (d5), K093950 (d5), K013806 (d5), K093806 (d5), K121115 (d5), K050041 (d5), K073556 (d5), K081623 (d5), K081700 (d5), K033810 (d5), K082172 (d5), K090763 (d5), K112802 (d5), K133039 (d5), K063875 (d5), K091214 (d5), K022324 (d5), K022325 (d5), K040907 (d5), K043583 (d5), K050819 (d5), K052614 (d5), K121425 (d5), K121437 (d5), K100359 (d5), K132502 (d5), K140769 (d5), K071264 (d5), K090949 (d5), K092038 (d5), K101700 (d5), K050259 (d5), K133477 (d5), K141420 (d5), K090988 (d6), K080101 (d6), K081284 (d6), K091243 (d6), K001941 (d6), K043185 (d6), K062863 (d6), K102343 (d6), K100618 (d6), K102156 (d6), K010170 (d6), K041906 (d6), K042842 (d6), K052792 (d6), K070369 (d6), K094035 (d6), K102487 (d6), K022949 (d6), K024096 (d6), K041119 (d6), K042962 (d6), K072022 (d6), K083393 (d6), K091445 (d6), K101074 (d6), K050636 (d6), K100736 (d6), K962705 (d6), K060473 (d6), K073375 (d6), K090139 (d6), K100176 (d6), K000636 (d6), K073527 (d6), K080667 (d6), K100271 (d6), K101056 (d6), K113760 (d6), K022599 (d6), K031712 (d6), K070598 (d6), K061925 (d6), K032396 (d7), K050327 (d7), K051588 (d7), K071535 (d7), K073102 (d7), K083762 (d7), K935484 (d7), K950827 (d7), K970501 (d7), K061940 (d7), K040022 (d7), K040593 (d7), K070946 (d7), K073624 (d7), K090289 (d7), K030665 (d7), K070561 (d7), K040962 (d7), K050981 (d7), K090390 (d7), K962823 (d7), K000684 (d7) — cited as predicate by K221943

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

Manufacturer compliance record — 3D-Side

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