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 K945687
Device Name ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
Applicant
SMITH AND NEPHEW DONJOY, INC.
2777 LOKER AVENUE WEST
CARSBAD,  CA  92008 -6601
Applicant Contact DAN W MILLER
Correspondent
SMITH AND NEPHEW DONJOY, INC.
2777 LOKER AVENUE WEST
CARSBAD,  CA  92008 -6601
Correspondent Contact DAN W MILLER
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/21/1994
Decision Date 06/22/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-