Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K991952 |
Device Name |
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
MARYBETH NAUGHTON |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
MARYBETH NAUGHTON |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 06/10/1999 |
Decision Date | 06/29/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|