BONE STAPLE(S)— 510(k) K904553

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K904553 for BONE STAPLE(S), Substantially Equivalent on 1990-12-21. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 1990-10-05
Decision date: 1990-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.