Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K142814 |
Device Name |
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial |
Applicant |
BIOMET MANUFACTURING LLC |
56 EAST BELL DR. |
WARSAW,
IN
46581
|
|
Applicant Contact |
TRACY BICKEL JOHNSON |
Correspondent |
BIOMET MANUFACTURING LLC |
56 EAST BELL DR. |
WARSAW,
IN
46581
|
|
Correspondent Contact |
TRACY BICKEL JOHNSON |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/29/2014 |
Decision Date | 06/25/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|