ENZA Zero-Profile Anterior Interbody Fusion

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Camber Spine Technologies

The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Enza Zero-profile Anterior Interbody Fusion.

Pre-market Notification Details

• Device ID: K153720
• 510k Number: K153720
• Device Name: ENZA Zero-Profile Anterior Interbody Fusion
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087
• Contact: Michael Black
• Correspondent: Justin Eggleton; Musculoskeletal Clinical Regulatory Advisors, LLC 1331 H Street NW, 12th Floor Washington, DC 20005
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-12-28
• Decision Date: 2016-05-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B030CB0010010	K153720	000
B030CB0010220	K153720	000
B030CB0010250	K153720	000
B030CB0010260	K153720	000
B030CB0010270	K153720	000
B030CB0010280	K153720	000
B030CB0010290	K153720	000
B030CB0010300	K153720	000
B030CB0010310	K153720	000
B030CB0010320	K153720	000
B030CB0010330	K153720	000
B030CB0010340	K153720	000
B030CB0010350	K153720	000
B030CB0010370	K153720	000
B030CB0010380	K153720	000
B030CB0010390	K153720	000
B030CC002360	K153720	000
B030CB0010210	K153720	000
B030CB0010200	K153720	000
B030CB0010020	K153720	000
B030CB0010030	K153720	000
B030CB0010040	K153720	000
B030CB0010070	K153720	000
B030CB0010080	K153720	000
B030CB0010090	K153720	000
B030CB0010100	K153720	000
B030CB0010110	K153720	000
B030CB0010120	K153720	000
B030CB0010130	K153720	000
B030CB0010140	K153720	000
B030CB0010150	K153720	000
B030CB0010160	K153720	000
B030CB0010170	K153720	000
B030CB0010180	K153720	000
B030CB0010190	K153720	000
B030CC002370	K153720	000
B030CC002380	K153720	000
B030EZAT232608090	K153720	000
B030EZAT263220150	K153720	000
B030EZAT263220170	K153720	000
B030EZAT303808090	K153720	000
B030EZAT303808110	K153720	000
B030EZAT303808130	K153720	000
B030EZAT303808150	K153720	000
B030EZAT303808170	K153720	000
B030EZAT303808190	K153720	000
B030EZAT303815110	K153720	000
B030EZAT303815130	K153720	000
B030EZAT303815150	K153720	000
B030EZAT303815170	K153720	000
B030EZAT303815190	K153720	000
B030EZAT303820130	K153720	000
B030EZAT303820150	K153720	000
B030EZAT303820170	K153720	000
B030EZAT263220130	K153720	000
B030EZAT263220110	K153720	000
B030EZAT232608110	K153720	000
B030EZAT232608130	K153720	000
B030EZAT232608150	K153720	000
B030EZAT232615090	K153720	000
B030EZAT232615110	K153720	000
B030EZAT232615130	K153720	000
B030EZAT232615150	K153720	000
B030EZAT263208090	K153720	000
B030EZAT263208110	K153720	000
B030EZAT263208130	K153720	000
B030EZAT263208150	K153720	000
B030EZAT263208170	K153720	000
B030EZAT263215110	K153720	000
B030EZAT263215130	K153720	000
B030EZAT263215150	K153720	000
B030EZAT263215170	K153720	000
B030EZAT303820190	K153720	000