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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K083070
Device Name TOGGLELOC SYSTEM
Applicant
BIOMET SPORTS MEDICINE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact ROBERT FRIDDLE
Correspondent
BIOMET SPORTS MEDICINE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact ROBERT FRIDDLE
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
JDR  
Date Received10/15/2008
Decision Date 12/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-