NOVEL FIT AND FILL STEM

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Novel Fit And Fill Stem.

Pre-market Notification Details

• Device ID: K122853
• 510k Number: K122853
• Device Name: NOVEL FIT AND FILL STEM
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Contact: Valerie Giambanco
• Correspondent: Valerie Giambanco; HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Product Code: MEH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-18
• Decision Date: 2013-02-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327311570	K122853	000
07613327311501	K122853	000
07613327311495	K122853	000
07613327311198	K122853	000
07613327310252	K122853	000
07613327310160	K122853	000
07613327310115	K122853	000