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 screw, fixation, bone
510(k) Number K153338
Device Name Tiger Cannulated Screw System
Applicant
Trilliant Surgical, LTD
6721 Portwest Dr Ste 160
Houston,  TX  77024
Applicant Contact Jon Olson
Correspondent
The OrthoMedix Group
1001 Oakwood Blvd
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/19/2015
Decision Date 01/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-