ASCENSION SILLICONE MCP— 510(k) K022892

Name: FDA 510(k) clearance K022892
Creator: U.S. Food and Drug Administration
Published: 2002-11-25

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K022892 for ASCENSION SILLICONE MCP, Substantially Equivalent on 2002-11-25. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code KYJ
Device class: Class 2
Regulation: 21 CFR 888.3230
Advisory panel: Orthopedic
Date received: 2002-08-30
Decision date: 2002-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21
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Adverse events under product code KYJ

product code KYJ

Injury: 210
Total: 210

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.