FDA Registration
Active
🇺🇸 United States
FUSION ORTHOPEDICS USA, LLC
Reg #: 3013365802
·
FEI: 3013365802
·
Expires 2026
Products
14
Proprietary Names
21
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- FUSION ORTHOPEDICS USA, LLC
- Registration Number
- 3013365802
- FEI Number
- 3013365802
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6859 E Rembrandt Ave, Ste 122
- City
- Mesa
- State
- AZ
- ZIP
- 85212
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181630
Owner / Operator
- Firm Name
- Fusion Orthopedics, LLC.
- Operator Number
- 10053147
- Address
- 4135 S Power Rd., Suite 110
- City
- Mesa
- State
- AZ
- Postal Code
- 85212
- Country
- US
- Correspondent
- Adam Cundiff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-02-28 |
| Prosthesis, Subtalar, Plug, Polymer | MJW | Class 2 | Orthopedic | No | 2019-02-12 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-05-04 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-05-04 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-06-18 |
| Template | HWT | Class 1 | Orthopedic | No | 2026-02-20 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2025-01-20 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2019-02-12 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2018-12-07 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2026-02-19 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2020-12-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2026-03-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-10-03 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-12-07 |
Proprietary Names
Revolution External Plating System
Lundeen Subtalar System
TalarLift STS
Trial Sizers
Bolo Button
SGARLATO LESSER TOE IMPLANT
HammerTech
FuzeFix Screw System
FuzeFix Large
FuzeFix Mini
FuzeFix Max FT
FuzeFix Twist Off
FibFix Nail
PolyLock Plating System
HammerTech Fixation System
Handles
Bone Tamp
PolyPrep
Bone Harvester
DynaBridge
Sgarlato Flexible Hinge Toe Implant
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device