Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K952970 |
Device Name |
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM |
Applicant |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
MARY C SPICER |
Correspondent |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
MARY C SPICER |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/27/1995 |
Decision Date | 01/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|