Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K093163 |
Device Name |
INTEGRA TOTAL WRIST FUSION SYSTEM |
Applicant |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
STEPHEN BEIER |
Correspondent |
INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
STEPHEN BEIER |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/06/2009 |
Decision Date | 12/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|