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 Bone Graft, Lumbar
510(k) Number K151276
Device Name DePuy Synthes T-PAL Ti Spacer
Applicant
Synthes USA Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact Eric Zhu
Correspondent
Synthes USA Products, LLC
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Eric Zhu
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/13/2015
Decision Date 06/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-