OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM

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

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Ha Generation Ii Acetabular Component System.

Pre-market Notification Details

• Device ID: K983382
• 510k Number: K983382
• Device Name: OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Marybeth Naughton
• Correspondent: Marybeth Naughton; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-25
• Decision Date: 1998-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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