Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
|
510(k) Number |
K971206 |
Device Name |
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING |
Applicant |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
MARGARET CROWE |
Correspondent |
HOWMEDICA CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
MARGARET CROWE |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/1997 |
Decision Date | 02/11/1998 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|