The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Corus Spinal System-x.
| Device ID | K212636 |
| 510k Number | K212636 |
| Device Name: | CORUS Spinal System-X |
| Classification | Arthroscope |
| Applicant | Providence Medical Technology, Inc. 4234 Hacienda Dr., Suite 150 Pleasanton, CA 94588 |
| Contact | Edward Liou |
| Correspondent | Edward Liou Providence Medical Technology, Inc. 4234 Hacienda Dr., Suite 150 Pleasanton, CA 94588 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-19 |
| Decision Date | 2021-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852776006584 | K212636 | 000 |