Device Classification Name |
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
More FDA Info for this Device |
510(K) Number |
K132496 |
Device Name |
Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained |
Applicant |
ARTHROSURFACE, INC.
28 FORGE PARKWAY
FRANKLIN, MA 02038 US
Other 510(k) Applications for this Company
|
Contact |
DAWN J WILSON
Other 510(k) Applications for this Contact |
Regulation Number |
000.0000
More FDA Info for this Regulation Number |
Classification Product Code |
LZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/09/2013 |
Decision Date |
02/26/2014 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
- |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|