Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
|
510(k) Number |
K993768 |
Device Name |
CITATION TMZF HA STEM |
Applicant |
HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Applicant Contact |
JENNIFER A DAUDELIN |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Correspondent Contact |
JENNIFER A DAUDELIN |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 11/08/1999 |
Decision Date | 01/21/2000 |
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
|
|
|