Contract manufacturerONYX MEDICAL LLC (Memphis, TN)TennesseeGeneral and plastic surgeryNeurologyOphthalmicOrthopedicGeneral hospitalRadiologyClass IClass IIUnclassified
ONYX MEDICAL LLC
Contract manufacturer · Memphis, TN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1043653 (openFDA record; or search FDA's registration database)
- FEI number
- 1043653
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Elos Medtech Onyx (FDA owner/operator no. 9002922)
- Registered address
- 1800 North Shelby Oaks Drive, Memphis, TN 38134
- Contract listings
- 121 device listings, 68 product codes, first listed Dec 4, 2012
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FXZ | Helmet, Surgical | Class I | General and plastic surgery | Contract manufacturing | Apr 20, 2017 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 23, 2013 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract manufacturing | Jan 16, 2017 |
| GEY | Motor, Surgical Instrument, Ac-Powered | Class I | General and plastic surgery | Contract manufacturing | Jul 22, 2015 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jan 16, 2017 |
| GFG | Bit, Surgical | Class I | General and plastic surgery | Contract manufacturing | Oct 23, 2014 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 4, 2012 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Class II | Neurology | Contract manufacturing | Dec 7, 2015 |
| HNO | Keratome, Ac-Powered | Class I | Ophthalmic | Contract manufacturing | Jan 16, 2017 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 14, 2013 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 14, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Jan 28, 2013 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Dec 19, 2012 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Jan 25, 2013 |
| HXI | Passer, Wire, Orthopedic | Class I | Orthopedic | Contract manufacturing | Jan 25, 2013 |
| HXK | Holder, Needle; Orthopedic | Class I | Orthopedic | Contract manufacturing | Mar 3, 2015 |
| HXP | Instrument, Bending Or Contouring | Class I | Orthopedic | Contract manufacturing | Jan 10, 2024 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | Class II | General and plastic surgery | Contract manufacturing | Jul 22, 2015 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | Orthopedic | Contract manufacturing | Feb 14, 2013 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jul 18, 2017 |
| JDS | Nail, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Feb 14, 2013 |
| JDW | Pin, Fixation, Threaded | Class II | Orthopedic | Contract manufacturing | Jan 14, 2013 |
| JEC | Component, Traction, Invasive | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 14, 2015 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | Mar 17, 2016 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract manufacturing | Jan 16, 2017 |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Dec 29, 2012 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 14, 2013 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Jan 14, 2013 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract manufacturing | Jan 31, 2013 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jan 16, 2017 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | Feb 15, 2016 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| LRN | Wire, Surgical | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Dec 6, 2012 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class II | Orthopedic | Contract manufacturing | Feb 1, 2013 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| LZY | Prosthesis, Hip, Hemi-, Femoral, Metal Ball | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jun 2, 2020 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Dec 29, 2012 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Jul 22, 2015 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jan 25, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jan 25, 2013 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Dec 9, 2015 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Sep 6, 2017 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jan 25, 2013 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Apr 20, 2017 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Feb 14, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Oct 21, 2013 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jan 16, 2017 |
| OSN | Software For Diagnosis/Treatment | Class II | Orthopedic | Contract manufacturing | Apr 20, 2017 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Jan 25, 2013 |