Device Classification Name |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
510(k) Number |
K060988 |
Device Name |
TOTAL AND HEMI SHOULDER SYSTEM |
Applicant |
DVO EXTREMITY SOLUTIONS, LLC |
P.O. BOX 205 |
DERBY,
CT
06418
|
|
Applicant Contact |
DINA WEISSMAN |
Correspondent |
DVO EXTREMITY SOLUTIONS, LLC |
P.O. BOX 205 |
DERBY,
CT
06418
|
|
Correspondent Contact |
DINA WEISSMAN |
Regulation Number | 888.3660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/10/2006 |
Decision Date | 12/06/2006 |
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
|
|
|