| Device Classification Name |
System, Facet Screw Spinal Device
|
| 510(k) Number |
K253676 |
| Device Name |
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) |
| Applicant |
| Providence Medical Technology, Inc. |
| 4234 Hacienda Dr. |
| Suite 150 |
|
Pleasanton,
CA
94588
|
|
| Applicant Contact |
Edward Liou |
| Correspondent |
| R. Dubois Consulting, LLC |
| 584 Rio Del Mar Blvd. |
|
Aptos,
CA
95003
|
|
| Correspondent Contact |
Roxanne Dubois |
| Classification Product Code |
|
| Date Received | 11/21/2025 |
| Decision Date | 05/14/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|