Device Classification Name |
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
|
510(k) Number |
K113271 |
Device Name |
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS |
Applicant |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. |
P.O BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
GARY BAKER |
Correspondent |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. |
P.O BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
GARY BAKER |
Regulation Number | 888.3330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/04/2011 |
Decision Date | 05/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|