FOUNDATION

Bone Grafting Material, Synthetic

OLYMPUS TERUMO BIOMATERIALS CORPORATION

The following data is part of a premarket notification filed by Olympus Terumo Biomaterials Corporation with the FDA for Foundation.

Pre-market Notification Details

• Device ID: K111087
• 510k Number: K111087
• Device Name: FOUNDATION
• Classification: Bone Grafting Material, Synthetic
• Applicant: OLYMPUS TERUMO BIOMATERIALS CORPORATION 5600 WISONSIN AVENUE, #509 Chevy Chase, MD 20815
• Contact: Patsy J Trisler
• Correspondent: Patsy J Trisler; OLYMPUS TERUMO BIOMATERIALS CORPORATION 5600 WISONSIN AVENUE, #509 Chevy Chase, MD 20815
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-04-19
• Decision Date: 2011-11-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14560245656828	K111087	000
14560245656811	K111087	000
20386040015254	K111087	000
20386040015247	K111087	000