Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K213877 |
Device Name |
ExactechGPS® System |
Applicant |
Blue Ortho |
22, Chemin du Vieux Chene |
Meylan,
FR
38240
|
|
Applicant Contact |
Matthieu Coic |
Correspondent |
Blue Ortho |
22, Chemin du Vieux Chene |
Meylan,
FR
38240
|
|
Correspondent Contact |
Matthieu Coic |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 12/13/2021 |
Decision Date | 05/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|