SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM— 510(k) K963045

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K963045 for SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM, Substantially Equivalent on 1997-02-13. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1996-08-05
Decision date: 1997-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.