CONDYLAR KNEE W/METAL ENCAPSULATED TIB— 510(k) K810230

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K810230 for CONDYLAR KNEE W/METAL ENCAPSULATED TIB, Substantially Equivalent on 1981-03-06. Applicant: Hexcel Medical.

Clearance details

Applicant: Hexcel Medical
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 1981-01-27
Decision date: 1981-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.