Device Classification Name |
posterior cervical screw system
|
510(k) Number |
K232167 |
Device Name |
VySpan™ PCT System |
Applicant |
Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 |
Tallahassee,
FL
32308
|
|
Applicant Contact |
Jordan Hendrickson |
Correspondent |
Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 |
Tallahassee,
FL
32308
|
|
Correspondent Contact |
Jordan Hendrickson |
Regulation Number | 888.3075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2023 |
Decision Date | 09/27/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|