OsteoFab Suture Anchors

Fastener, Fixation, Nondegradable, Soft Tissue

Oxford Performance Materials, Inc.

The following data is part of a premarket notification filed by Oxford Performance Materials, Inc. with the FDA for Osteofab Suture Anchors.

Pre-market Notification Details

• Device ID: K190915
• 510k Number: K190915
• Device Name: OsteoFab Suture Anchors
• Classification: Fastener, Fixation, Nondegradable, Soft Tissue
• Applicant: Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074
• Contact: Andrus Maandi
• Correspondent: Andrus Maandi; Oxford Performance Materials, Inc. 30 South Satellite Road South Windsor, CT 06074
• Product Code: MBI
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-09
• Decision Date: 2019-07-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850004435069	K190915	000
00850004435052	K190915	000
00850004435045	K190915	000
00850004435007	K190915	000