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

Name: FDA 510(k) clearance K810230
Creator: U.S. Food and Drug Administration
Published: 1981-03-06

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. Device class: 2.

Clearance details

Applicant: Hexcel Medical
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
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 ↗

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K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

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K812669 — SEATTLE II TOTAL HIP SYSTEM1981-10-02
K812687 — BRIGHAM II TOTAL HIP SYSTEM1981-10-02
K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE1981-09-08

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.