Spine Wave Anterior Cervical Spine System

Intervertebral Fusion Device With Integrated Fixation, Cervical

SPINE WAVE, INC.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Spine Wave Anterior Cervical Spine System.

Pre-market Notification Details

• Device ID: K162760
• 510k Number: K162760
• Device Name: Spine Wave Anterior Cervical Spine System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Cervical
• Applicant: SPINE WAVE, INC. 3 ENTERPRISE DR SUITE 210 Shelton, CT 06484
• Contact: Amnon Talmor
• Correspondent: Amnon Talmor; SPINE WAVE, INC. 3 ENTERPRISE DR SUITE 210 Shelton, CT 06484
• Product Code: OVE
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-30
• Decision Date: 2017-02-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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