DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE

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 Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip, Wedge.

Pre-market Notification Details

• Device ID: K122015
• 510k Number: K122015
• Device Name: DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah, NJ 07430
• Contact: Christie Pencinger
• Correspondent: Christie Pencinger; HOWMEDICA OSTEONICS CORP. 325 CORPORATE DR Mahwah, NJ 07430
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-07-10
• Decision Date: 2013-02-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327142631	K122015	000
07613327033755	K122015	000
07613327033762	K122015	000
07613327033786	K122015	000
07613327048216	K122015	000
07613327048933	K122015	000
07613327049930	K122015	000
07613327142525	K122015	000
07613327142532	K122015	000
07613327142549	K122015	000
07613327142556	K122015	000
07613327142563	K122015	000
07613327142570	K122015	000
07613327142587	K122015	000
07613327142594	K122015	000
07613327142600	K122015	000
07613327142617	K122015	000
07613327142624	K122015	000
04546540276520	K122015	000