SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS

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

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Scorpio Knee System Tibial Inserts And Patellar Components.

Pre-market Notification Details

• Device ID: K051977
• 510k Number: K051977
• Device Name: SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Contact: Karen Ariemma
• Correspondent: Karen Ariemma; HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-21
• Decision Date: 2005-10-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327029772	K051977	000
07613327029659	K051977	000
07613327029642	K051977	000
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07613327029789	K051977	000