CORIN BIPOLAR PROSTHESIS— 510(k) K925897

Name: FDA 510(k) clearance K925897
Creator: U.S. Food and Drug Administration
Published: 1993-08-09

Substantially Equivalent

Corin Orthopedic Products

FDA 510(k) clearance K925897 for CORIN BIPOLAR PROSTHESIS, Substantially Equivalent on 1993-08-09. Applicant: Corin Orthopedic Products. Device class: 2.

Clearance details

Applicant: Corin Orthopedic Products
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 1992-11-19
Decision date: 1993-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Corin Orthopedic Products

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K931752 — CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION1994-10-07
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K934166 — NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION1994-09-07
K925866 — CENATOR TOTAL HIP SYSTEM1993-09-23

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.