ASTRA-OCT Spine System
FDA 510(k) K181350 · Spinecraft, LLC
510(k) numberK181350
Submission
- Device name
- ASTRA-OCT Spine System
- Applicant
- Spinecraft, LLC
Westmont, IL, US - Received
- May 22, 2018
- Decision date
- July 6, 2018
- 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…
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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 |
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| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLO · Traditional | 07/20/2023SE |
| K223273 | ASTRA Spine SystemNKB · Traditional | 12/22/2022SE |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage SystemODP · Traditional | 09/30/2021SE |
| K211323 | ASTRA Spine SystemNKB · Special | 06/03/2021SE |
| K143683 | APEX-DL Spine SystemNKB · Traditional | 05/22/2015SE |
| K150417 | Astra Spine SystemNKB · Traditional | 05/19/2015SE |
| K131521 | Velox Anterior Cervical Plate SystemKWQ · Traditional | 12/24/2013SE |
| K132603 | Apex Spine SystemNKB · Traditional | 11/20/2013SE |
Questions and answers
When was ASTRA-OCT Spine System cleared by the FDA?
ASTRA-OCT Spine System (K181350) received a 510(k) decision of Substantially Equivalent on July 6, 2018, 45 days after the submission was received.
What is the product code of K181350?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.