SPIRA-C Open Matrix Cervical Interbody

Intervertebral Fusion Device With Bone Graft, Cervical

Camber Spine Technologies

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Spira-c Open Matrix Cervical Interbody.

Pre-market Notification Details

• Device ID: K172446
• 510k Number: K172446
• Device Name: SPIRA-C Open Matrix Cervical Interbody
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: Camber Spine Technologies 418 E. Lancaster Avenue Wayne, PA 19087
• Contact: Michael Black
• Correspondent: Justin Eggleton; MCRA 1050 K Street NW, Suite 1000 Washington, DC 20001
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-14
• Decision Date: 2017-11-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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