ASCENSION SILICONE PIP— 510(k) K082231

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K082231 for ASCENSION SILICONE PIP, Substantially Equivalent on 2009-01-12. Applicant: Ascension Orthopedics, Inc..

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code KYJ
Advisory panel: Orthopedic
Date received: 2008-08-07
Decision date: 2009-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.