VySpan PCT System
FDA 510(k) K232167 · Vy Spine, LLC
510(k) numberK232167
Submission
- Device name
- VySpan PCT System
- Applicant
- Vy Spine, LLC
Tallahassee, FL, US - Received
- July 21, 2023
- Decision date
- September 27, 2023
- 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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| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/02/2026SE |
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | 03/27/2026SE |
| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | 03/19/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | 01/07/2026SE |
| K241783 | FortiVy OsteoVy Lumbar IBFMAX · Traditional | 03/18/2025SE |
| K242784 | Vy Spine VyLam Laminoplasty SystemNQW · Special | 10/16/2024SE |
| K233807 | LumiVy Lumbar IBF SystemMAX · Traditional | 09/24/2024SE |
| K231836 | ClariVy Cervical IBF SystemODP · Traditional | 10/30/2023SE |
| K231744 | VyLink Spinal Screw SystemNKB · Traditional | 10/13/2023SE |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | 10/10/2023SE |
| K230414 | ClariVy Cervical IBF SystemODP · Special | 05/12/2023SE |
Questions and answers
When was VySpan PCT System cleared by the FDA?
VySpan PCT System (K232167) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 68 days after the submission was received.
What is the product code of K232167?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.