Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K100448 |
Device Name |
ASCENSION MODULAR TOTAL SHOULDER SYSTEM |
Applicant |
ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD., STE. 100 |
AUSTIN,
TX
78754 -3832
|
|
Applicant Contact |
STANLEY J HARRIS |
Correspondent |
ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD., STE. 100 |
AUSTIN,
TX
78754 -3832
|
|
Correspondent Contact |
STANLEY J HARRIS |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/17/2010 |
Decision Date | 08/30/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|