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 Spinal Vertebral Body Replacement Device
510(k) Number K031914
Device Name SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
Applicant
Spinal Concepts, Inc.
5301 Riata Park Ct., Bldg. F
Austin,  TX  78727
Applicant Contact LISA PETERSON
Correspondent
Spinal Concepts, Inc.
5301 Riata Park Ct., Bldg. F
Austin,  TX  78727
Correspondent Contact LISA PETERSON
Regulation Number888.3060
Classification Product Code
MQP  
Date Received06/20/2003
Decision Date 07/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-