TRAUMACEM™ V+ Injectable Bone Cement

Bone Cement

Synthes (USA) Products, LLC

The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Traumacem™ V+ Injectable Bone Cement.

Pre-market Notification Details

• Device ID: K170802
• 510k Number: K170802
• Device Name: TRAUMACEM™ V+ Injectable Bone Cement
• Classification: Bone Cement
• Applicant: Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380
• Contact: Christopher J. Medberry
• Correspondent: Christopher J. Medberry; Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380
• Product Code: LOD
• CFR Regulation Number: 888.3027 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-17
• Decision Date: 2017-09-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10886982262257	K170802	000