Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K193618 |
Device Name |
ExactechGPS System |
Applicant |
Blue Ortho |
6 Allee de Bethleem |
Gieres,
FR
38610
|
|
Applicant Contact |
Matthieu Coic |
Correspondent |
Blue Ortho |
6 Allee de Bethleem |
Gieres,
FR
38610
|
|
Correspondent Contact |
Matthieu Coic |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/26/2019 |
Decision Date | 09/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|