Proficient® Posterior Cervical Spine System
FDA 510(k) K181440 · Spine Wave, Inc.
510(k) numberK181440
Submission
- Device name
- Proficient® Posterior Cervical Spine System
- Applicant
- Spine Wave, Inc.
Shelton, CT, US - Received
- June 1, 2018
- Decision date
- July 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKG – Posterior Cervical Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Specialty
- Orthopedic
- Implant
- Yes
Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following…
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| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | CarboFix Orthopedics , Ltd. | 03/16/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 01/21/2026SE |
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | Icotec AG | 11/12/2025SE |
| K253129 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K251725 | ANAX OCT Spinal SystemNKG · Special | Cg Medtech Co., Ltd. | 06/25/2025SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | Met One Technologies, LLC | 05/20/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | Signature Orthopaedics Pty, Ltd. | 05/13/2025SE |
| K250332 | Virage® OCT Spinal Fixation SystemNKG · Traditional | Highridge Medical, LLC | 04/04/2025SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | MiRus, LLC | 11/19/2024SE |
More from MiRus, LLC
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| 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® Posterior Cervical Spine System cleared by the FDA?
Proficient® Posterior Cervical Spine System (K181440) received a 510(k) decision of Substantially Equivalent on July 30, 2018, 59 days after the submission was received.
What is the product code of K181440?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.