Total clearances
6
2021-06-03 → 2026-04-16
Name variants in FDA filings: SpineCraft / Spinecraft, LLC
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| ODP |
Intervertebral Fusion Device With Bone Graft, Cervical |
Class II |
Orthopedic |
2 |
2026-04-16 |
| NKB |
Thoracolumbosacral Pedicle Screw System |
Class II |
Orthopedic |
2 |
2022-12-22 |
| KWQ |
Appliance, Fixation, Spinal Intervertebral Body |
Class II |
Orthopedic |
1 |
2026-03-04 |
| OLO |
Orthopedic Stereotaxic Instrument |
Class II |
Neurology |
1 |
2023-07-20 |
Filings
All 510(k) clearances (6)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-04-16 |
K253260 |
ORIO-3D Cage System |
ODP |
Class II |
Orthopedic |
| 2026-03-04 |
K260015 |
ANTERIS Thoracolumbar Plate System |
KWQ |
Class II |
Orthopedic |
| 2023-07-20 |
K223301 |
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System |
OLO |
Class II |
Neurology |
| 2022-12-22 |
K223273 |
ASTRA Spine System |
NKB |
Class II |
Orthopedic |
| 2021-09-30 |
K211935 |
ORIO-Ti Intervertebral Body Fusion Cage System |
ODP |
Class II |
Orthopedic |
| 2021-06-03 |
K211323 |
ASTRA Spine System |
NKB |
Class II |
Orthopedic |