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 K082574
Device Name MAXTORQUE MINI CANNULATED SCREW SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 W. MARKET ST.
SUITE 205
AKRON,  OH  44313
Applicant Contact DEREK LEWIS
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 W. MARKET ST.
SUITE 205
AKRON,  OH  44313
Correspondent Contact DEREK LEWIS
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/05/2008
Decision Date 12/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-