Total clearances
4
2020-02-20 → 2023-10-19
Name variants in FDA filings: Flospine, LLC / Flospine
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| PEK |
Spinous Process Plate |
Class II |
Orthopedic |
1 |
2023-10-19 |
| ODP |
Intervertebral Fusion Device With Bone Graft, Cervical |
Class II |
Orthopedic |
1 |
2023-02-24 |
| KWQ |
Appliance, Fixation, Spinal Intervertebral Body |
Class II |
Orthopedic |
1 |
2021-04-07 |
| MAX |
Intervertebral Fusion Device With Bone Graft, Lumbar |
Class II |
Orthopedic |
1 |
2020-02-20 |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-10-19 |
K232484 |
KeyLift Expandable Interlaminar Stabilization System |
PEK |
Class II |
Orthopedic |
| 2023-02-24 |
K223231 |
Ti-Largo Cervical Interbody System |
ODP |
Class II |
Orthopedic |
| 2021-04-07 |
K210182 |
PANAMA Anterior Cervical Plate (ACP) System |
KWQ |
Class II |
Orthopedic |
| 2020-02-20 |
K193255 |
Largo PEEK Interbody System |
MAX |
Class II |
Orthopedic |