KINEMATIC ROTATING HINGE TOTAL KNEE PR.

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Kinematic Rotating Hinge Total Knee Pr..

Pre-market Notification Details

• Device ID: K811630
• 510k Number: K811630
• Device Name: KINEMATIC ROTATING HINGE TOTAL KNEE PR.
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Trunnion-bearing
• Applicant: HOWMEDICA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: LGE
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-06-09
• Decision Date: 1981-07-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327046656	K811630	000