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, multiple component
510(k) Number K122210
Device Name NEWFIX EXTERNAL FIXATION SYSTEM
Applicant
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V
PO BOX 506
SOUTH LYON,  MI  48178
Applicant Contact ROBERT J BARD
Correspondent
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V
PO BOX 506
SOUTH LYON,  MI  48178
Correspondent Contact ROBERT J BARD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received07/25/2012
Decision Date 04/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-