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 K073177
Device Name PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855 -0627
Applicant Contact JONATHAN M GILBERT
Correspondent
PIONEER SURGICAL TECHNOLOGY
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855 -0627
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received11/13/2007
Decision Date 05/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-