OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES

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(r) Restoration Monolithic Ii Hip Stem Series.

Pre-market Notification Details

• Device ID: K946234
• 510k Number: K946234
• Device Name: OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Terry Jarosz
• Correspondent: Terry Jarosz; 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: 1994-12-22
• Decision Date: 1995-04-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327018332	K946234	000
07613327018325	K946234	000
07613327018318	K946234	000
07613327018301	K946234	000
07613327018295	K946234	000
07613327018288	K946234	000
07613327018271	K946234	000