• 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 Component, Traction, Invasive
510(k) Number K792561
Device Name MINI-H-FIXATION
Applicant
GENY MEDICAL, INC.
66 ARGONAUT # 170
ALISO VIEJO,  CA  92656
Correspondent
GENY MEDICAL, INC.
66 ARGONAUT # 170
ALISO VIEJO,  CA  92656
Regulation Number888.3040
Classification Product Code
JEC  
Date Received12/12/1979
Decision Date 12/19/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-