The following data is part of a premarket notification filed by Providence Medical Technology, Inc. with the FDA for Pmt Facet Screw.
| Device ID | K183589 |
| 510k Number | K183589 |
| Device Name: | PMT Facet Screw |
| Classification | System, Facet Screw Spinal Device |
| Applicant | Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300 Pleasanton, CA 94588 |
| Contact | Edward Liou |
| Correspondent | Janie Mandrusov Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300 Pleasanton, CA 94588 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-10-11 |
| Summary: | summary |