Total clearances
9
2020-03-06 → 2025-07-22
Name variants in FDA filings: Alafair Biosciences / Alafair Biosciences, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| JXI |
Cuff, Nerve |
Class II |
Neurology |
4 |
2025-07-22 |
| FTM |
Mesh, Surgical |
Class II |
General, Plastic Surgery |
3 |
2021-10-29 |
| OWW |
— |
— |
— |
2 |
2025-07-18 |
Filings
All 510(k) clearances (9)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-07-22 |
K251505 |
VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) |
JXI |
Class II |
Neurology |
| 2025-07-18 |
K251655 |
VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) |
OWW |
— |
— |
| 2025-07-17 |
K251175 |
VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) |
JXI |
Class II |
Neurology |
| 2024-06-14 |
K240817 |
VersaWrap |
OWW |
— |
— |
| 2023-11-02 |
K232029 |
VersaWrap Nerve Protector |
JXI |
Class II |
Neurology |
| 2021-10-29 |
K213163 |
VersaWrap |
FTM |
Class II |
General, Plastic Surgery |
| 2021-03-09 |
K203600 |
VersaWrap |
FTM |
Class II |
General, Plastic Surgery |
| 2020-09-14 |
K201631 |
VersaWrap Nerve Protector |
JXI |
Class II |
Neurology |
| 2020-03-06 |
K200311 |
VersaWrap Tendon Protector |
FTM |
Class II |
General, Plastic Surgery |