• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name plate, fixation, bone
510(k) Number K071105
Device Name OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM
Original Applicant
OSTEOMED L.P.
3885 arapaho rd.
addison,  TX  75001
Original Contact dawn d tindall
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/19/2007
Decision Date 07/30/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-