• 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 orthosis, spinal pedicle fixation
510(k) Number K040493
Device Name OUTOLOGOUS SPINAL FIXATION SYSTEM
Applicant
ORTHOPEDIC SCIENCES, INC
4329 GRAYDON RD.
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
ORTHOPEDIC SCIENCES, INC
4329 GRAYDON RD.
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received02/26/2004
Decision Date 09/03/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-