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

Name: FDA 510(k) clearance K896614
Creator: U.S. Food and Drug Administration
Published: 1990-01-09

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.. Device class: 3.

Clearance details

Applicant: Synergy Orthopaedics Intl., Inc.
Product code: Code JDL
Device class: Class 3
Regulation: 21 CFR 888.3320
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

Download summary PDF View on FDA.gov ↗

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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.