CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION— 510(k) K931752

Substantially Equivalent

Corin Orthopedic Products

FDA 510(k) clearance K931752 for CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION, Substantially Equivalent on 1994-10-07. Applicant: Corin Orthopedic Products. Device class: 2.

Clearance details

Applicant
Corin Orthopedic Products
Product code
Code KWL
Device class
Class 2
Regulation
21 CFR 888.3360
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tampa, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KWL

product code KWL
Injury
523
Total
523

Source: openFDA MAUDE database, through . 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.