Device Classification Name |
Spinous Process Plate
|
510(k) Number |
K201704 |
Device Name |
CoFix System |
Applicant |
Paradigm Spine GmbH |
375 River Park Circle |
Marquette,
MI
49855
|
|
Applicant Contact |
Branko Sostarko |
Correspondent |
MCRA, LLC |
1050 K Street NW |
Suite 1000 |
Washington,
DC
20001
|
|
Correspondent Contact |
Justin Eggleton |
Regulation Number | 888.3050
|
Classification Product Code |
|
Date Received | 06/22/2020 |
Decision Date | 08/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|