OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS

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

HOWMEDICA OSTEONICS CORP.

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

Pre-market Notification Details

• Device ID: K991952
• 510k Number: K991952
• Device Name: OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Marybeth Naughton
• Correspondent: Marybeth Naughton; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-10
• Decision Date: 1999-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327101270	K991952	000
07613327023701	K991952	000
07613327023718	K991952	000
07613327023725	K991952	000
07613327023732	K991952	000
07613327023749	K991952	000
07613327023794	K991952	000
07613327024388	K991952	000
07613327024395	K991952	000
07613327024401	K991952	000
07613327024418	K991952	000
07613327024425	K991952	000
07613327024432	K991952	000
07613327024456	K991952	000
07613327024494	K991952	000
07613327038569	K991952	000
07613327101201	K991952	000
07613327023671	K991952	000