Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K032300 |
Device Name |
ACCOLADE-J HIP STEM SERIES |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
LORRAINE MONTEMURRO |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
LORRAINE MONTEMURRO |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/25/2003 |
Decision Date | 10/09/2003 |
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
|
|
|