S.A.F. ACETABULAR CUP WITH POROUS COATING— 510(k) K896614

Substantially Equivalent for Some Indications

Synergy Orthopaedics Intl., Inc.

FDA 510(k) clearance K896614 for S.A.F. ACETABULAR CUP WITH POROUS COATING, Substantially Equivalent for Some Indications on 1990-01-09. Applicant: Synergy Orthopaedics Intl., Inc..

Clearance details

Applicant: Synergy Orthopaedics Intl., Inc.
Product code: Code JDL
Advisory panel: Orthopedic
Date received: 1989-11-21
Decision date: 1990-01-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code JDL

product code JDL

Injury: 285
Total: 285

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.