Altus Spine Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Altus Partners, LLC

The following data is part of a premarket notification filed by Altus Partners, Llc with the FDA for Altus Spine Cervical Plate System.

Pre-market Notification Details

• Device ID: K163061
• 510k Number: K163061
• Device Name: Altus Spine Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380
• Contact: Claudia Hill
• Correspondent: Claudia Hill; Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-01
• Decision Date: 2017-02-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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