• 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 | Inspections
 


New Search Back To Search Results
Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K121693
Device Name A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
Applicant
SAPPHIRE MEDICAL GROUP, INC
815 iris lane
vero beach,  FL  32963
Applicant Contact robert poggie
Correspondent
SAPPHIRE MEDICAL GROUP, INC
815 iris lane
vero beach,  FL  32963
Correspodent Contact robert poggie
Regulation Number888.3080
Classification Product Code
MAX  
Date Received06/07/2012
Decision Date 12/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-