SYNTHES BIORESORBABLE SUTURE ANCHOR— 510(k) K994161

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K994161 for SYNTHES BIORESORBABLE SUTURE ANCHOR, Substantially Equivalent on 2000-07-28. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1999-12-09
Decision date: 2000-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.