NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION— 510(k) K934166

Name: FDA 510(k) clearance K934166
Creator: U.S. Food and Drug Administration
Published: 1994-09-07

Substantially Equivalent for Some Indications

Corin Orthopedic Products

FDA 510(k) clearance K934166 for NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION, Substantially Equivalent for Some Indications on 1994-09-07. Applicant: Corin Orthopedic Products. Device class: 2.

Clearance details

Applicant: Corin Orthopedic Products
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1993-08-27
Decision date: 1994-09-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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K931752 — CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION1994-10-07
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K925866 — CENATOR TOTAL HIP SYSTEM1993-09-23
K925897 — CORIN BIPOLAR PROSTHESIS1993-08-09

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.