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 K080526
Device Name SIERRA SYSTEM
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 Number888.3050
Classification Product Code
KWP  
Date Received02/26/2008
Decision Date 04/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-