Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, uncemented
|
510(k) Number |
K993601 |
Device Name |
HOWMEDICA OSTEONICS FEMORAL HEADS |
Applicant |
HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Applicant Contact |
NANCY J RIEDER |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Correspondent Contact |
NANCY J RIEDER |
Regulation Number | 888.3360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/25/1999 |
Decision Date | 11/16/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|