Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K003801 |
Device Name |
ANATOMICAL PRESS-FIT HUMERAL STEM |
Applicant |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
MITCHELL A DHORITY |
Correspondent |
SULZER ORTHOPEDICS, INC. |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
MITCHELL A DHORITY |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/08/2000 |
Decision Date | 02/28/2001 |
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
|
|
|