CoCr Head— 510(k) K211047

Name: FDA 510(k) clearance K211047
Creator: U.S. Food and Drug Administration
Published: 2023-01-10

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K211047 for CoCr Head, Substantially Equivalent on 2023-01-10. Applicant: Zimmer GmbH. Device class: 2.

Clearance details

Applicant: Zimmer GmbH
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2021-04-08
Decision date: 2023-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winterthur, CH

Download summary PDF View on FDA.gov ↗

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K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26
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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.