Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
510(k) Number |
K150855 |
Device Name |
H-MAX S Femoral Hip System |
Applicant |
Limacorporate S.P.A. |
Via Nazionale, 52 |
Villanova di San Daniele,
IT
33038
|
|
Applicant Contact |
Sara Viel |
Correspondent |
Limacorporate S.P.A. |
Via Nazionale, 52 |
Villanova di San Daniele,
IT
33038
|
|
Correspondent Contact |
Stephen J Peoples |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/31/2015 |
Decision Date | 10/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|