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 K852026
Device Name FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
Applicant
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Applicant Contact JAMES RITTER
Correspondent
Warsaw Orthopedic, Inc.
P.O. Box 1157
Warsaw,  IN  46580
Correspondent Contact JAMES RITTER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/08/1985
Decision Date 05/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-