PENNSYLVANIA HOSPITAL HIP SYS— 510(k) K841437

Name: FDA 510(k) clearance K841437
Creator: U.S. Food and Drug Administration
Published: 1984-06-25

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K841437 for PENNSYLVANIA HOSPITAL HIP SYS, Substantially Equivalent on 1984-06-25. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1984-04-06
Decision date: 1984-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K253675 — OsteoRemedies Hip Spacer System2025-12-23
K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

More clearances from Biomet, Inc.

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K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

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.