SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene

Intervertebral Fusion Device With Bone Graft, Lumbar

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Seaspine Spacer System- Hollywood Nanometalene, Hollywood Vi Nanometalene, Ventura Nanometalene; Seaspine Cambria Nanometalene.

Pre-market Notification Details

• Device ID: K162715
• 510k Number: K162715
• Device Name: SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008
• Contact: Gina Flores
• Correspondent: Gina Flores; SeaSpine Orthopedics Corporation 5770 Armada Drive 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: 2016-09-29
• Decision Date: 2016-10-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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