The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Dtrax Spinal System.
| Device ID | K180876 |
| 510k Number | K180876 |
| Device Name: | DTRAX Spinal System |
| Classification | Arthroscope |
| Applicant | Providence Medical Technology, Inc. 3857 Hopyard Rd. Suite 300 Pleasanton, CA 94588 |
| Contact | Edward Liou |
| Correspondent | Edward Liou Providence Medical Technology, Inc. 3857 Hopyard Rd. Suite 300 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 | 2018-04-03 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852776006086 | K180876 | 000 |