IOI COCR UNIPOLAR PROSTHESIS— 510(k) K934159

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K934159 for IOI COCR UNIPOLAR PROSTHESIS, Substantially Equivalent on 1994-07-21. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1993-08-27
Decision date: 1994-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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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.