Altus Spine Sochi OCT Spinal System
FDA 510(k) K210887 · Altus Partners, LLC
510(k) numberK210887
Submission
- Device name
- Altus Spine Sochi OCT Spinal System
- Applicant
- Altus Partners, LLC
West Chester, PA, US - Received
- March 25, 2021
- Decision date
- August 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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…
Other 510(k)s with product code NKG
| 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 |
|---|---|---|
| K243419 | Altus Spine Navigation SystemOLO · Traditional | 05/08/2025SE |
| K211027 | Altus Spine Pedicle Screw SystemNKB · Traditional | 09/16/2022SE |
| K211837 | Altus Spine Interbody Standalone Fusion SystemOVD · Traditional | 04/19/2022SE |
| K200922 | Altus Spine HA Pedicle Screw SystemNKB · Special | 01/26/2021SE |
| K200322 | Altus Spine Pedicle Screw SystemNKB · Traditional | 06/02/2020SE |
| K183084 | Fuji Cervical Plate SystemKWQ · Special | 05/29/2019SE |
| K182406 | Altus Spine Interbody Fusion SystemMAX · Traditional | 02/22/2019SE |
| K181339 | Altus Spine Pedicle Screw SystemNKB · Traditional | 07/24/2018SE |
| K181281 | Altus Spine Pedicle Screw SystemNKB · Special | 06/11/2018SE |
| K170553 | Altus Spine Interbody Fusion SystemMAX · Traditional | 12/01/2017SE |
Questions and answers
When was Altus Spine Sochi OCT Spinal System cleared by the FDA?
Altus Spine Sochi OCT Spinal System (K210887) received a 510(k) decision of Substantially Equivalent on August 20, 2021, 148 days after the submission was received.
What is the product code of K210887?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.