OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics All Polyethylene Glenoid Shoulder Component.

Pre-market Notification Details

• Device ID: K962082
• 510k Number: K962082
• Device Name: OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Robert A Koch
• Correspondent: Robert A Koch; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-05-29
• Decision Date: 1996-08-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327138283	K962082	000
07613327138269	K962082	000
07613327138238	K962082	000
07613327138177	K962082	000