Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K151739 |
Device Name |
Revision Femoral Stem |
Applicant |
LIMACORPORATE S.P.A. |
VIA NAZIONALE 52 |
VILLANOVA DI SAN DANIELE,
IT
33038
|
|
Applicant Contact |
EMANUELE BUTTAZZONI |
Correspondent |
PEOPLES & ASSOCIATES -STEPHEN J. PEOPLES, VMD, MS |
411 AUDITORIUM BLVD. |
WINONA LAKE,
IN
46590
|
|
Correspondent Contact |
STEPHEN PEOPLES |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/26/2015 |
Decision Date | 11/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|