The following data is part of a premarket notification filed by Providence Medical Technology, Inc with the FDA for Pmt Facet Fixation System (pmt Ffs).
| Device ID | K220951 |
| 510k Number | K220951 |
| Device Name: | PMT Facet Fixation System (PMT FFS) |
| Classification | System, Facet Screw Spinal Device |
| Applicant | Providence Medical Technology, Inc 4234 Hacienda Drive, Suite 150 Pleasanton, CA 94588 |
| Contact | Edward Liou |
| Correspondent | Edward Liou Providence Medical Technology, Inc 4234 Hacienda Drive, Suite 150 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 | 2022-04-01 |
| Decision Date | 2022-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852776006607 | K220951 | 000 |
| 00852776006591 | K220951 | 000 |