Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal
|
510(k) Number |
K842234 |
Device Name |
NEW JERSEY FEMORAL STEM |
Applicant |
ENDOMEDICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ENDOMEDICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 888.3360
|
Classification Product Code |
|
Date Received | 06/05/1984 |
Decision Date | 07/20/1984 |
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
|
|
|