• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name orthosis, spinal pedicle fixation, for degenerative disc disease
510(k) Number K121299
Device Name STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
Original Applicant
SAFE ORTHOPAEDICS
parc des bellevues
allee r.luxembourg-bat californie
eragny sur oise,  FR 95610
Original Contact pierre dumouchel
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received04/30/2012
Decision Date 07/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-