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Schanz Screw Adaptor Long

Model AMCH07550 · AUGMEDICS LTD · DI 07290113780903

SBF — Orthopedic Augmented Reality · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-14 · 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.

12342020-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 4/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device0809120107081112010405070809101201020403080903
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0803
2021-0901
2021-1202
2022-0102
2022-0701
2022-0801
2022-1102
2022-1202
2023-0102
2023-0402
2023-0502
2023-0702
2023-0804
2023-0902
2023-1001.5
2023-1204
2024-0101
2024-0201
2024-0401
2025-0301
2025-0802
2025-0901
2026-0301
This device (reports/month)Average device in SBF (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K211188 — cites (transitively): K070106 (d1), K190929 (d1), K170011 (d2), K172418 (d2), K050438 (d3), K153660 (d3), K163622 (d3), K170167 (d3), K150216 (d4), K992927 (d4), K062650 (d4), K142107 (d4), K052632 (d5), K123023 (d5), K112387 (d6) — cited as predicate by K220905, K223769

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

Manufacturer compliance record — AUGMEDICS LTD

Nothing in the loaded window.