KINEMATIC II ROTATING HINGE KNEE— 510(k) K992346

Name: FDA 510(k) clearance K992346
Creator: U.S. Food and Drug Administration
Published: 1999-08-12

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K992346 for KINEMATIC II ROTATING HINGE KNEE, Substantially Equivalent on 1999-08-12. Applicant: Howmedica Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code LGE
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1999-07-13
Decision date: 1999-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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