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 spinal vertebral body replacement device
510(k) Number K080699
Device Name NOVEL SPINAL SPACER SYSTEM
Applicant
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Applicant Contact MARY STANNERS
Correspondent
ALPHATEC SPINE, INC.
2051 PALOMAR AIRPORT ROAD
SUITE 100
CARLSBAD,  CA  92011
Correspondent Contact MARY STANNERS
Regulation Number888.3060
Classification Product Code
MQP  
Subsequent Product Code
MAX  
Date Received03/12/2008
Decision Date 05/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-