XTAC

Mesh, Surgical, Polymeric

OSTEOGENICS, INC.

The following data is part of a premarket notification filed by Osteogenics, Inc. with the FDA for Xtac.

Pre-market Notification Details

• Device ID: K061934
• 510k Number: K061934
• Device Name: XTAC
• Classification: Mesh, Surgical, Polymeric
• Applicant: OSTEOGENICS, INC. 7781 LAKEVIEW DR. Burlington, WI 53105 -8119
• Contact: Michael Deutsch
• Correspondent: Michael Deutsch; OSTEOGENICS, INC. 7781 LAKEVIEW DR. Burlington, WI 53105 -8119
• Product Code: FTL
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-07
• Decision Date: 2007-07-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810805000194	K061934	000