Device Classification Name |
pedicle screw placement guide
|
510(k) Number |
K181883 |
Device Name |
FIREFLY® Midline Navigation Guide |
Applicant |
Mighty Oak Medical Inc. |
750 W. Hampden Avenue, Suite 120 |
Englewood,
CO
80110
|
|
Applicant Contact |
Mark A. Wylie |
Correspondent |
Mighty Oak Medical Inc. |
750 W. Hampden Avenue, Suite 120 |
Englewood,
CO
80110
|
|
Correspondent Contact |
Mark A. Wylie |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 07/13/2018 |
Decision Date | 10/03/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|