• 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 K071726
Device Name ZUMA
Applicant
SEASPINE, INC.
2302 LA MIRADA DR.
vista,  CA  92081 -7862
Applicant Contact ethel bernal
Correspondent
SEASPINE, INC.
2302 LA MIRADA DR.
vista,  CA  92081 -7862
Correspondent Contact ethel bernal
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/25/2007
Decision Date 10/23/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-