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 spinous process plate
510(k) Number K121924
Device Name INTEGRA INTERSPINOUS PROCESS SYSTEM
Applicant
SEASPINE, INC.
2302 la Mirada Dr
VISTA,  CA  92081
Applicant Contact NICK M CORDARO
Correspondent
SEASPINE, INC.
2302 la Mirada Dr
VISTA,  CA  92081
Correspondent Contact NICK M CORDARO
Regulation Number888.3050
Classification Product Code
PEK  
Date Received07/02/2012
Decision Date 09/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-