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 appliance, fixation, spinal interlaminal
510(k) Number K042673
Device Name ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Applicant
ALPHATEC/NEXMED
6110 CORTE DEL CEDRO
CARLSBAD,  CA  92009
Applicant Contact ELLEN A YARNALL
Correspondent
ALPHATEC/NEXMED
6110 CORTE DEL CEDRO
CARLSBAD,  CA  92009
Correspondent Contact ELLEN A YARNALL
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received09/29/2004
Decision Date 10/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-