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, Nail/Blade/Plate Combination, Single Component
510(k) Number K992837
Device Name 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
Applicant
Synthes (Usa)
1600 Russell Rd.
Paoli,  PA  19301
Applicant Contact ANGELA J SILVESTRI
Correspondent
Synthes (Usa)
1600 Russell Rd.
Paoli,  PA  19301
Correspondent Contact ANGELA J SILVESTRI
Regulation Number888.3030
Classification Product Code
KTW  
Date Received08/23/1999
Decision Date 10/25/1999
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
-
-