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 K052405
Device Name STERLING INTERFERENC SCREW HT
Applicant
Regeneration Technologies, Inc.
11621 Research Cir.
P.O. Box 2650
Alachua,  FL  32616
Applicant Contact CARRIE HARTILL
Correspondent
Regeneration Technologies, Inc.
11621 Research Cir.
P.O. Box 2650
Alachua,  FL  32616
Correspondent Contact CARRIE HARTILL
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/01/2005
Decision Date 11/16/2005
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
-
-