FDA Registration
Active
🇺🇸 United States
ONYX MEDICAL LLC
Reg #: 1043653
·
FEI: 1043653
·
Expires 2026
Products
68
Proprietary Names
18
Establishment Types
1
Classifications
68
Registration Details
- Registration Name
- ONYX MEDICAL LLC
- Registration Number
- 1043653
- FEI Number
- 1043653
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1800 North Shelby Oaks Drive
- City
- MEMPHIS
- State
- TN
- ZIP
- 38134
- Country
- US
Owner / Operator
- Firm Name
- Elos Medtech Onyx
- Operator Number
- 9002922
- Address
- 1800 N Shelby Oaks Dr, --
- City
- Memphis
- State
- TN
- Postal Code
- 38134
- Country
- US
- Correspondent
- Jodie L Gilmore
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-01-28 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2017-01-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2022-01-06 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2015-03-03 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-01-16 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2017-01-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-01-16 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-01-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-01-16 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-12-29 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2012-12-29 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2012-12-29 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2015-03-03 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2012-12-04 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-01-28 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2013-01-25 |
| Helmet, Surgical | FXZ | Class 1 | General, Plastic Surgery | No | 2017-04-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-01-25 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2013-02-01 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2024-01-10 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2017-04-20 |
| Component, Traction, Invasive | JEC | Class 2 | Orthopedic | No | 2013-01-23 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2012-12-29 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2015-07-22 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2017-01-16 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2017-07-18 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2017-09-06 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2013-01-14 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2012-12-29 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2012-12-29 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-06-02 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2014-10-23 |
| Software For Diagnosis/Treatment | OSN | Class 2 | Orthopedic | No | 2017-04-20 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2015-12-09 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2015-12-07 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-02-14 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2013-02-14 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2013-02-14 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2013-02-14 |
| Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | JWJ | Class 2 | Orthopedic | No | 2016-03-17 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-06-02 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2017-01-16 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2017-01-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-23 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2012-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2015-07-22 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2015-07-22 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2015-07-22 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2012-12-29 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2017-01-16 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-19 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2013-02-14 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2016-02-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-06 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2013-01-25 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2012-12-29 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2015-07-22 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2013-01-31 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2012-12-29 |
Proprietary Names
Biomet Headless Compression And Twist-Off Screws
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Plate, Fixation, Bone
DePuy Synthes
HEX-FIX
Bone Pins
CAS Fix fluted 3.2mm
Stryker
Instratek
XTRAFIX
JOURNEY
Pin, Fixation, Threaded
T2 ICF System
Half Pin
Ace
ALPS Proximal Humerus Plating System
D-RAD Smart Pack
K-Wire, Threaded Tip
Instrument
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)