MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modular Rotating Hinge Knee Tibial Rotating Component.

Pre-market Notification Details

• Device ID: K001957
• 510k Number: K001957
• Device Name: MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584
• Contact: Jennifer A Daudelin
• Correspondent: Jennifer A Daudelin; HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-27
• Decision Date: 2000-07-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327045215	K001957	000
07613327045208	K001957	000