Device Classification Name |
Arthroscope
|
510(k) Number |
K212636 |
Device Name |
CORUS Spinal System-X |
Applicant |
Providence Medical Technology, Inc. |
4234 Hacienda Dr., Suite 150 |
Pleasanton,
CA
94588
|
|
Applicant Contact |
Edward Liou |
Correspondent |
Providence Medical Technology, Inc. |
4234 Hacienda Dr., Suite 150 |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
Edward Liou |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 08/19/2021 |
Decision Date | 10/15/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|