ASTRA Spine System
FDA 510(k) K223273 · Spinecraft, LLC
510(k) numberK223273
Submission
- Device name
- ASTRA Spine System
- Applicant
- Spinecraft, LLC
Westmont, IL, US - Received
- October 24, 2022
- Decision date
- December 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Other 510(k)s with product code NKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 09/04/2026SE |
| K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…NKB · Traditional | MANTIZ Co., Ltd. | 07/24/2026SE |
| K253943 | Tiger 2 SystemNKB · Traditional | Zavation Medical Products, LLC | 07/24/2026SE |
| K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional | Alphatec Spine, Inc. | 07/14/2026SE |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special | S.M.A.I.O | 07/01/2026SE |
| K253045 | Socko Vimax Spinal Fixation SystemNKB · Traditional | Socko Medical Co., Ltd. | 06/17/2026SE |
| K251251 | ChanPin Pedicle Screw Spinal SystemNKB · Traditional | Chanpin Medtak Co., Ltd. | 06/09/2026SE |
| K260989 | Varion Thoracolumbar Fixation SystemNKB · Traditional | Kyocera Medical Technologies Inc. (KMTI) | 05/15/2026SE |
| K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional | Globus Medical, Inc. | 05/07/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | L&K BIOMED Co., Ltd. | 05/05/2026SE |
More from L&K BIOMED Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253260 | ORIO-3D Cage SystemODP · Traditional | 04/16/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | 03/04/2026SE |
| K223301 | ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemOLO · Traditional | 07/20/2023SE |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage SystemODP · Traditional | 09/30/2021SE |
| K211323 | ASTRA Spine SystemNKB · Special | 06/03/2021SE |
| K181350 | ASTRA-OCT Spine SystemNKG · Traditional | 07/06/2018SE |
| 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 Spine System cleared by the FDA?
ASTRA Spine System (K223273) received a 510(k) decision of Substantially Equivalent on December 22, 2022, 59 days after the submission was received.
What is the product code of K223273?
The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.