OSFERION

Filler, Bone Void, Calcium Compound

OLYMPUS TERUMO BIOMATERIALS CORPORATION

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

Pre-market Notification Details

• Device ID: K080065
• 510k Number: K080065
• Device Name: OSFERION
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610
• Contact: Laura Storms-tyler
• Correspondent: Laura Storms-tyler; OLYMPUS TERUMO BIOMATERIALS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-01-10
• Decision Date: 2008-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04560245656975	K080065	000
04560245656968	K080065	000
04560245656951	K080065	000
04560245656913	K080065	000
04560245656906	K080065	000
04560245656890	K080065	000
04560245656883	K080065	000