HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE— 510(k) K925607

Name: FDA 510(k) clearance K925607
Creator: U.S. Food and Drug Administration
Published: 1993-11-08

Substantially Equivalent for Some Indications

Zimmer, Inc.

FDA 510(k) clearance K925607 for HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE, Substantially Equivalent for Some Indications on 1993-11-08. Applicant: Zimmer, Inc.. Device class: 2.

Clearance details

Applicant: Zimmer, Inc.
Product code: Product code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1992-11-05
Decision date: 1993-11-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.