Proficient (TM) Facet Screw Spine System
FDA 510(k) K142980 · Spine Wave, Inc.
510(k) numberK142980
Submission
- Device name
- Proficient (TM) Facet Screw Spine System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- October 15, 2014
- Decision date
- January 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | Vy Spine, LLC | 03/19/2026SE |
| K251714 | Ion-CMRW · Traditional | SurGenTec, LLC | 01/16/2026SE |
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| K252153 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 10/16/2025SE |
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| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | Spinal Elements, Inc. | 05/21/2025SE |
More from Spinal Elements, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine SystemPML · Traditional | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | 05/29/2026SE |
| K243816 | Testa TP Pivoting Spacer SystemMAX · Traditional | 06/27/2025SE |
| K251131 | Annex® 2 Adjacent Level SystemNKB · Traditional | 06/06/2025SE |
| K243514 | Salvo® Robotic Navigation InstrumentsOLO · Traditional | 04/03/2025SE |
| K240685 | Salvo® Spine SystemNKB · Traditional | 05/06/2024SE |
| K231275 | Exceed Biplanar Expandable Interbody SystemMAX · Traditional | 07/25/2023SE |
| K222362 | Salvo® Spine SystemNKB · Special | 08/29/2022SE |
| K202476 | Salvo® Spine SystemNKB · Traditional | 11/05/2020SE |
| K192526 | Spine Wave Navigated InstrumentsOLO · Special | 10/10/2019SE |
Questions and answers
When was Proficient (TM) Facet Screw Spine System cleared by the FDA?
Proficient (TM) Facet Screw Spine System (K142980) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 93 days after the submission was received.
What is the product code of K142980?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.