FDA Registration
Active
🇺🇸 United States
CROSSROADS EXTREMITY SYSTEMS LLC
Reg #: 3020584246
·
FEI: 3020584246
·
Expires 2026
Products
25
Proprietary Names
32
Establishment Types
2
Classifications
25
Registration Details
- Registration Name
- CROSSROADS EXTREMITY SYSTEMS LLC
- Registration Number
- 3020584246
- FEI Number
- 3020584246
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6423 Shelby View Dr, Suite 101
- City
- Memphis
- State
- TN
- ZIP
- 38134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152306
Owner / Operator
- Firm Name
- CrossRoads Extremity Systems LLC
- Operator Number
- 10048591
- Address
- 6423 Shelby View Dr, Suite 101
- City
- Memphis
- State
- TN
- Postal Code
- 38134
- Country
- US
- Correspondent
- Angela Marik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-12-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-12-13 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2020-12-28 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-11-08 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-05-03 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2023-11-08 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2018-05-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2018-05-03 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2018-05-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-12-23 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-11-08 |
| Bender | HXW | Class 1 | Orthopedic | No | 2018-05-03 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2018-05-03 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2018-05-03 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2019-05-10 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2018-05-03 |
| Probe | HXB | Class 1 | Orthopedic | No | 2018-05-03 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2024-02-21 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2018-05-03 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2023-11-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2026-01-07 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-05-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-05-03 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-05-03 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2018-05-03 |
Proprietary Names
MotoBAND
MotoBAND Max
VERO
SPEEDBUTTON ANCHOR SYSTEM
FootHold System
CrossRoads Tray System
MotoBand CP
DynaForce
TriLEAP Plating System
CrossTIE Instraosseous Fixation System
STROPP
MotoBAND CP
DynaFORCE MotoBAND Max
DynaFORCE VERO
DynaFORCE
Pin
Allograft Template
MotoBAND CP Implant System
CrossTIE
CrossRoads Screw System
MotoCLIP
CrossRoads Modular Tray System
MotoBAND CP DynaForce
Broach
MotoCLIP Superelastic Fusion System
CrossCLIP Implant System
DynaFORCE HiMAX
DynaFORCE MotoCLIP MAX
MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System
HiMAX
MotoCLIP/HiMAX Step Staple Implant System
CrossRoads Bone Screw
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device