OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Scorpio Posterior Cruciate Retaining Total Knee System.

Pre-market Notification Details

• Device ID: K974556
• 510k Number: K974556
• Device Name: OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Contact: Donna S Wilson
• Correspondent: Donna S Wilson; OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-05
• Decision Date: 1998-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327044423	K974556	000
07613327028003	K974556	000
07613327027990	K974556	000
07613327027983	K974556	000
07613327027976	K974556	000
07613327027969	K974556	000
07613327027952	K974556	000
07613327027945	K974556	000
07613327027938	K974556	000
07613327027921	K974556	000
07613327027914	K974556	000
07613327027907	K974556	000
07613327027891	K974556	000
07613327027884	K974556	000
07613327027877	K974556	000
07613327027860	K974556	000
07613327028010	K974556	000
07613327028027	K974556	000
07613327044355	K974556	000
07613327028164	K974556	000
07613327028157	K974556	000
07613327028140	K974556	000
07613327028133	K974556	000
07613327028126	K974556	000
07613327028119	K974556	000
07613327028102	K974556	000
07613327028096	K974556	000
07613327028089	K974556	000
07613327028072	K974556	000
07613327028065	K974556	000
07613327028058	K974556	000
07613327028041	K974556	000
07613327028034	K974556	000
07613327027853	K974556	000