Contract manufacturerABLE MEDICAL DEVICES (Gwinn, MI)MichiganGeneral and plastic surgeryOrthopedicNeurologyClass IClass IIUnclassified
ABLE MEDICAL DEVICES
Contract manufacturer · Gwinn, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3014680795 (openFDA record; or search FDA's registration database)
- FEI number
- 3014680795
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Able Medical Devices (FDA owner/operator no. 10058122)
- Registered address
- 512 Fourth Street, Gwinn, MI 49841
- Contract listings
- 74 device listings, 39 product codes, first listed Nov 20, 2018
- 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 |
|---|---|---|---|---|---|
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Dec 8, 2022 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Dec 15, 2022 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |
| HTC | Pliers, Surgical | Class I | General and plastic surgery | Contract manufacturing | Dec 28, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Nov 20, 2019 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Dec 18, 2025 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Dec 18, 2025 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| JDQ | Cerclage, Fixation | Class II | Orthopedic | Contract manufacturing | Dec 16, 2024 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 28, 2023 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class II | Orthopedic | Contract manufacturing | Dec 18, 2025 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jun 26, 2019 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Dec 22, 2020 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 28, 2023 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| LXI | Guide, Drill, Ligament | Class I | General and plastic surgery | Contract manufacturing | Dec 18, 2025 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class II | Orthopedic | Contract manufacturing | Dec 28, 2023 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jun 2, 2020 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Dec 28, 2023 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Dec 18, 2025 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| MRW | System, Facet Screw Spinal Device | Unclassified | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jun 26, 2019 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Nov 20, 2018 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Feb 8, 2022 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 22, 2020 |
| OZI | Internal Hinged Elbow Fixator | Class II | Orthopedic | Contract manufacturing | Dec 28, 2023 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Apr 19, 2022 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract manufacturing | Nov 21, 2021 |