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 System, External Fixator (With Metallic Invasive Components)
510(k) Number K122208
Device Name EXTERNAL FIXATOR SYSTEM
Applicant
Christopher D. Endara
11767 S. Dixie Hwy.
#313
Miami,  FL  33156
Applicant Contact CHRISTOPHER ENDARA
Correspondent
Christopher D. Endara
11767 S. Dixie Hwy.
#313
Miami,  FL  33156
Correspondent Contact CHRISTOPHER ENDARA
Regulation Number888.3040
Classification Product Code
NDK  
Date Received07/25/2012
Decision Date 12/20/2012
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
-
-