The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Proficient (tm) Facet Screw Spine System.
| Device ID | K142980 |
| 510k Number | K142980 |
| Device Name: | Proficient (TM) Facet Screw Spine System |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SPINE WAVE, INC. 3 ENTERPRISE DRIVE SUITE 210 Shelton, CT 06484 |
| Contact | Roaida Johnson |
| Correspondent | Roaida Johnson SPINE WAVE, INC. 3 ENTERPRISE DRIVE SUITE 210 Shelton, CT 06484 |
| 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 | 2014-10-15 |
| Decision Date | 2015-01-16 |
| Summary: | summary |