OsteoSync™ Ti Dental Mesh

Plate, Bone

Sites Medical, LLC

The following data is part of a premarket notification filed by Sites Medical, Llc with the FDA for Osteosync™ Ti Dental Mesh.

Pre-market Notification Details

• Device ID: K202918
• 510k Number: K202918
• Device Name: OsteoSync™ Ti Dental Mesh
• Classification: Plate, Bone
• Applicant: Sites Medical, LLC 5865 E State Road 14 Columbia City, IN 46725
• Contact: Greg Stalcup
• Correspondent: Karen E Warden; BackRoads Consulting PO BOX 566 Chesterland, OH 44026
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-29
• Decision Date: 2021-07-14