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 integrated fixation, lumbar
510(k) Number K082926
Device Name ZUMA, MODEL 55-XXXX/56-XXXX
Applicant
SEASPINE, INC.
2302 LA MIRADA DR.
VISTA,  CA  92081 -7862
Applicant Contact JEFF BRITTAN
Correspondent
SEASPINE, INC.
2302 LA MIRADA DR.
VISTA,  CA  92081 -7862
Correspondent Contact JEFF BRITTAN
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MQP  
Date Received10/01/2008
Decision Date 12/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-