P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT— 510(k) K900638

Name: FDA 510(k) clearance K900638
Creator: U.S. Food and Drug Administration
Published: 1990-04-30

Substantially Equivalent

Johnson & Johnson International

FDA 510(k) clearance K900638 for P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT, Substantially Equivalent on 1990-04-30. Applicant: Johnson & Johnson International. Device class: 2.

Clearance details

Applicant: Johnson & Johnson International
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1990-02-09
Decision date: 1990-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

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K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

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K946245 — TIELLE* HYDROPOLYMER DRESSING1995-04-11
K942383 — DERMIVIEW CLEAR TAPE1994-08-22
K922918 — BARRIER SAF-TE HYDROGEL DRAPE1993-07-06

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.