PERFECTA TOTAL HIP SYSTEM, HA COATED— 510(k) K915190

Name: FDA 510(k) clearance K915190
Creator: U.S. Food and Drug Administration
Published: 1992-12-24

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K915190 for PERFECTA TOTAL HIP SYSTEM, HA COATED, Substantially Equivalent on 1992-12-24. Applicant: Orthomet, Inc.. Device class: 2.

Clearance details

Applicant: Orthomet, Inc.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1991-11-22
Decision date: 1992-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT1994-12-28
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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.