OSTEONICS ALUMINA C-TAPER HEAD

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Alumina C-taper Head.

Pre-market Notification Details

• Device ID: K971409
• 510k Number: K971409
• Device Name: OSTEONICS ALUMINA C-TAPER HEAD
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Kate Sutton
• Correspondent: Kate Sutton; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-04-16
• Decision Date: 1997-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327101249	K971409	000
07613327101188	K971409	000
07613327101171	K971409	000
07613327101164	K971409	000