Contract manufacturerLH MEDICAL CORPORATION (Fort Wayne, IN)IndianaEar, nose and throatGeneral and plastic surgeryOrthopedicGeneral hospitalNeurologyClass IIClass IClass III
LH MEDICAL CORPORATION
Contract manufacturer · Fort Wayne, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010057495 (openFDA record; or search FDA's registration database)
- FEI number
- 3010057495
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- LH Medical Corporation (FDA owner/operator no. 10042802)
- Registered address
- 6932 Gettysburg Pike, Fort Wayne, IN 46804
- Contract listings
- 76 device listings, 59 product codes, first listed Jan 2, 2013
- 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 |
|---|---|---|---|---|---|
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | Jan 27, 2026 |
| FST | Light, Surgical, Fiberoptic | Class II | General and plastic surgery | Contract manufacturing | Jan 27, 2026 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 2, 2013 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Jan 2, 2013 |
| GED | Brush, Dermabrasion, Manual | Class I | General and plastic surgery | Contract manufacturing | Jan 2, 2013 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Mar 20, 2023 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Jan 27, 2026 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jun 28, 2018 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Mar 25, 2022 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 27, 2026 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Jan 7, 2022 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Jul 14, 2025 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | Apr 1, 2021 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Class II | Orthopedic | Contract manufacturing | Jun 28, 2018 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | Class III | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| JDS | Nail, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 27, 2026 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract manufacturing | Jan 27, 2026 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Class III | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Apr 11, 2014 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jan 11, 2022 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 2, 2013 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 13, 2022 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Class II | Orthopedic | Contract manufacturing | Apr 7, 2021 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 13, 2020 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Oct 29, 2018 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | Contract manufacturing | Apr 7, 2021 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Jan 27, 2026 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Apr 11, 2014 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Apr 11, 2014 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Mar 22, 2016 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Jan 27, 2026 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 12, 2019 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Oct 29, 2018 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 12, 2019 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 18, 2017 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract manufacturing | Aug 18, 2017 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Aug 18, 2017 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Jan 27, 2026 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Mar 22, 2016 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 12, 2019 |
| PDQ | Neurosurgical Nerve Locator | Class II | Ear, nose and throat | Contract manufacturing | Jan 27, 2026 |
| PEK | Spinous Process Plate | Class II | Orthopedic | Contract manufacturing | Apr 9, 2014 |
| PHM | Intervertebral Fusion Device With Bone Graft, Thoracic | Class II | Orthopedic | Contract manufacturing | Jan 27, 2026 |