NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD

Filler, Bone Void, Calcium Compound

NovaBone Products, LLC

The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Novabone Porous - Synthetic Bone Graft Scaffold.

Pre-market Notification Details

• Device ID: K090731
• 510k Number: K090731
• Device Name: NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615
• Contact: David M Gaisser
• Correspondent: David M Gaisser; NovaBone Products, LLC 13709 PROGRESS BLVD., #33 Alachua, FL 32615
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-19
• Decision Date: 2009-04-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00813909011226	K090731	000
00813909010915	K090731	000
00813909010922	K090731	000
00813909010946	K090731	000
00813909010953	K090731	000
00813909010960	K090731	000
00813909011141	K090731	000
00813909011158	K090731	000
00813909011219	K090731	000
00813909010908	K090731	000