Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K171715 |
Device Name |
HammerTube System |
Applicant |
Paragon 28 |
4B Inverness Ct. E., STE 280 |
Englewood,
CO
80112
|
|
Applicant Contact |
Frank S. Bono |
Correspondent |
BackRoads Consulting, Inc |
PO Box 566 |
Chesterland,
OH
44026 -0566
|
|
Correspondent Contact |
Karen E. Warden |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/09/2017 |
Decision Date | 03/05/2018 |
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
|
|
|