Device Classification Name |
Staple, Fixation, Bone
|
510(k) Number |
K153129 |
Device Name |
dynaMX Tabbed Staple |
Applicant |
MX Orthopedics, Corp. |
1 Broadway, 14th Floor |
Cambridge,
MA
02142
|
|
Applicant Contact |
Howard L. Schrayer |
Correspondent |
MX Orthopedics, Corp. |
1 Broadway, 14th Floor |
Cambridge,
MA
02142
|
|
Correspondent Contact |
Howard L. Schrayer |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 10/30/2015 |
Decision Date | 01/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|