Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K072020 |
Device Name |
RESTORATION ADM SYSTEM |
Applicant |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
KAREN ARIEMMA |
Correspondent |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
KAREN ARIEMMA |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/23/2007 |
Decision Date | 10/18/2007 |
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
|
|
|