NOVEL ALIF SPINAL SPACER SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Novel Alif Spinal Spacer System.

Pre-market Notification Details

• Device ID: K090782
• 510k Number: K090782
• Device Name: NOVEL ALIF SPINAL SPACER SYSTEM
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008
• Contact: Mary Stanners
• Correspondent: Mary Stanners; ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-23
• Decision Date: 2009-04-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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