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 Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
510(k) Number K132496
Device Name ARTHROSURFACE TOEMOTION
Applicant
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Applicant Contact DAWN J WILSON
Correspondent
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Correspondent Contact DAWN J WILSON
Classification Product Code
LZJ  
Date Received08/09/2013
Decision Date 02/26/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-