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 K002082
Device Name SPEEDLINK TRANSVERSE CONNECTOR
Applicant
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Applicant Contact DAVID M HOOPER
Correspondent
SPINAL CONCEPTS, INC.
12012 TECHNOLOGY BLVD., #100
AUSTIN,  TX  78727
Correspondent Contact DAVID M HOOPER
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received07/10/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-