S.A.F. ACETABULAR CUP— 510(k) K895157

Substantially Equivalent

Synergy Orthopaedics Intl., Inc.

FDA 510(k) clearance K895157 for S.A.F. ACETABULAR CUP, Substantially Equivalent on 1989-12-01. Applicant: Synergy Orthopaedics Intl., Inc..

Clearance details

Applicant: Synergy Orthopaedics Intl., Inc.
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 1989-08-10
Decision date: 1989-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.