Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 intervertebral fusion device with bone graft, lumbar
510(k) Number K072791
Device Name ORACLE SPACER, OPAL SPACER
Applicant
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact STACEY BONNELL
Correspondent
SYNTHES SPINE
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact STACEY BONNELL
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received10/01/2007
Decision Date 12/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-