KINEMATIC ROTATING HINGE TOTAL KNEE PR.— 510(k) K811630

Name: FDA 510(k) clearance K811630
Creator: U.S. Food and Drug Administration
Published: 1981-07-01

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K811630 for KINEMATIC ROTATING HINGE TOTAL KNEE PR., Substantially Equivalent on 1981-07-01. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code LGE
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1981-06-09
Decision date: 1981-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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