Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K936126 |
Device Name |
HOWMEDICS DRG FEMORAL COMPONENT |
Applicant |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Applicant Contact |
ROBERT E SMITH |
Correspondent |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070 -2584
|
|
Correspondent Contact |
ROBERT E SMITH |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 12/23/1993 |
Decision Date | 10/20/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|