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 Appliance, Fixation, Spinal Interlaminal
510(k) Number K983904
Device Name ROGOZINSKI SPINAL ROD SYSTEM
Applicant
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact SHARON L MURPHY
Correspondent
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact SHARON L MURPHY
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH  
Date Received11/03/1998
Decision Date 12/22/1998
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
-
-