STRYKER PATIENT SPECIFIC POLYMER IMPLANT

Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS

The following data is part of a premarket notification filed by Howmedica Osteonics Corp Dba Stryker Orthopaedics with the FDA for Stryker Patient Specific Polymer Implant.

Pre-market Notification Details

• Device ID: K103010
• 510k Number: K103010
• Device Name: STRYKER PATIENT SPECIFIC POLYMER IMPLANT
• Classification: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
• Applicant: HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430
• Contact: Stephanie Fitts
• Correspondent: Stephanie Fitts; HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430
• Product Code: KKY
• CFR Regulation Number: 878.3500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-12
• Decision Date: 2010-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613252133575	K103010	000
07613252133568	K103010	000
07613252133551	K103010	000
07613252133544	K103010	000
07613252133537	K103010	000