• 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 K972494
Device Name DEPUY DUPONT ABSORBABLE SET SCREW
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact SALLY FOUST
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact SALLY FOUST
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/03/1997
Decision Date 10/01/1997
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
-
-