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 Cerclage, Fixation
510(k) Number K081622
Device Name UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
Applicant
Abbott Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Applicant Contact MARITZA ELIAS
Correspondent
Abbott Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Correspondent Contact MARITZA ELIAS
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received06/10/2008
Decision Date 08/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-