Fusion Orthopedics, LLC
Mesa, AZ, US
Fusion Orthopedics, LLC appears in FDA device records in Mesa, AZ. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Fusion Orthopedics, LLC between 2016 and 2024. The busiest year on record is 2019, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242091 | Bolo Button System | HTN | Substantially Equivalent | |
| K211843 | PolyLock Plating System | HRS | Substantially Equivalent | |
| K210159 | IntraLock System | HWC | Substantially Equivalent | |
| K193377 | TopLock Anchor System | MBI | Substantially Equivalent | |
| K202959 | PolyLock Plating System | HRS | Substantially Equivalent | |
| K192323 | PolyLock Small Bone Plating System | HRS | Substantially Equivalent | |
| K190136 | Fusion Silastic System | KWH | Substantially Equivalent | |
| K182342 | IntraLock Lapidus System | HWC | Substantially Equivalent | |
| K182684 | HammerTechTM Fixation System | HWC | Substantially Equivalent | |
| K181815 | DynaBridge | JDR | Substantially Equivalent | |
| K170624 | TalarLift STS | HWC | Substantially Equivalent | |
| K170038 | FuzeFix Screw System | HWC | Substantially Equivalent | |
| K161449 | HammerTech Fixation System | HWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain