Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K070170 |
Device Name |
DALL-MILES SYSTEM |
Applicant |
STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
PATRICIA SETTI-LAPERCH |
Correspondent |
STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
PATRICIA SETTI-LAPERCH |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/18/2007 |
Decision Date | 03/02/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|