Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K153720
Device Name ENZA Zero-Profile Anterior Interbody Fusion
Applicant
Camber Spine Technologies
418 E. Lancaster Ave.
Wayne,  PA  19087
Applicant Contact Michael Black
Correspondent
Musculoskeletal Clinical Regulatory Advisors, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
OVD  
Date Received12/28/2015
Decision Date 05/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-