Total clearances
5
2020-11-24 → 2024-12-23
Name variants in FDA filings: Fusion Orthopedics, LLC / Fusion Orthopedics
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| HRS |
Plate, Fixation, Bone |
Class II |
Orthopedic |
2 |
2022-03-04 |
| HTN |
Washer, Bolt Nut |
Class II |
Orthopedic |
1 |
2024-12-23 |
| HWC |
Screw, Fixation, Bone |
Class II |
Orthopedic |
1 |
2021-07-23 |
| MBI |
Fastener, Fixation, Nondegradable, Soft Tissue |
Class II |
Orthopedic |
1 |
2020-11-25 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-12-23 |
K242091 |
Bolo Button System |
HTN |
Class II |
Orthopedic |
| 2022-03-04 |
K211843 |
PolyLock Plating System |
HRS |
Class II |
Orthopedic |
| 2021-07-23 |
K210159 |
IntraLock System |
HWC |
Class II |
Orthopedic |
| 2020-11-25 |
K193377 |
TopLock Anchor System |
MBI |
Class II |
Orthopedic |
| 2020-11-24 |
K202959 |
PolyLock Plating System |
HRS |
Class II |
Orthopedic |