Xenco Medical Posterior Cervical System
FDA 510(k) K161478 · Xenco Medical, LLC
510(k) numberK161478
Submission
- Device name
- Xenco Medical Posterior Cervical System
- Applicant
- Xenco Medical, LLC
San Diego, CA, US - Received
- May 31, 2016
- Decision date
- September 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K243673 | Xenco Medical CancelleX Cervical Interbody SystemODP · Traditional | 01/29/2025SE |
| K223059 | Xenco Medical InterAlign Cervical Interbody SystemOVE · Traditional | 06/07/2023SE |
| K213456 | Xenco Medical Multilevel CerviKitKWQ · Traditional | 12/21/2021SE |
| K191074 | Sorrento Bone Graft SubstituteMQV · Traditional | 09/27/2019SE |
| K190364 | CancelleX Porous Titanium Lumbar Interbody DeviceMAX · Traditional | 04/18/2019SE |
| K173933 | Sorrento Bioglass Bone Graft SubstituteMQV · Traditional | 09/13/2018SE |
| K180373 | CancelleX Porous Titanium Lumbar Interbody DeviceMAX · Traditional | 08/24/2018SE |
| K170611 | SETx Pedicle Screw SystemNKB · Traditional | 05/25/2017SE |
| K160313 | Xenco Medical Cervical Interbody SystemOVE · Traditional | 10/21/2016SE |
| K160986 | Xenco Medical Pedicle Screw SystemNKB · Special | 05/04/2016SE |
Questions and answers
When was Xenco Medical Posterior Cervical System cleared by the FDA?
Xenco Medical Posterior Cervical System (K161478) received a 510(k) decision of Substantially Equivalent on September 6, 2016, 98 days after the submission was received.
What is the product code of K161478?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.