HINGED KNEE— 510(k) K982160

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K982160 for HINGED KNEE, Substantially Equivalent on 1999-03-17. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code KRO
Advisory panel: Orthopedic
Date received: 1998-06-19
Decision date: 1999-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code KRO

product code KRO

Death: 19
Injury: 4,841
Total: 4,860

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.