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 Rod, Fixation, Intramedullary And Accessories
510(k) Number K160545
Device Name GAP ENDO-EXO MEDULLARY SYSTEM
Applicant
Pega Medical, Inc.
1111 Autoroute Chomedey
Laval,  CA H7W 5J8
Applicant Contact Ariel R. Dujovne
Correspondent
Pega Medical, Inc.
1111 Autoroute Chomedey
Laval,  CA H7W 5J8
Correspondent Contact Ariel R. Dujovne
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/26/2016
Decision Date 11/23/2016
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
-
-