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, Cervical
510(k) Number K150053
Device Name STALIF C; STALIF C-Ti
Applicant
Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester,  PA  19380
Applicant Contact John Parry
Correspondent
MCRA, LLC
1331 H STREET NW, 12TH FLOOR
WASHINGTON,  DC  20005
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
OVE  
Date Received01/12/2015
Decision Date 06/24/2015
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
-
-