Device Classification Name |
prosthesis, hip, femoral component, cemented, metal
|
510(k) Number |
K212431 |
Device Name |
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve |
Applicant |
Biomet, Inc. |
56 East Bell Drive |
PO Box 587 |
Warsaw,
IN
46581
|
|
Applicant Contact |
Gregory Foster |
Correspondent |
Biomet, Inc. |
56 East Bell Drive |
PO Box 587 |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Gregory Foster |
Regulation Number | 888.3360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/04/2021 |
Decision Date | 02/07/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|