The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Corus Spinal System.
| Device ID | K190201 |
| 510k Number | K190201 |
| Device Name: | CORUS Spinal System |
| Classification | Arthroscope |
| Applicant | Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300 Pleasanton, CA 94588 |
| Contact | Janie Mandrusov |
| Correspondent | Janie Mandrusov Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300 Pleasanton, CA 94588 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852776006430 | K190201 | 000 |
| 10852776006505 | K190201 | 000 |