Contract manufacturerC&A Tool Engineering, Inc. Auburn Plant (Auburn, IN)IndianaNeurologyOrthopedicGeneral and plastic surgeryClass IIClass IClass III
C&A Tool Engineering, Inc. Auburn Plant
Contract manufacturer · Auburn, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3014252644 (openFDA record; or search FDA's registration database)
- FEI number
- 3014252644
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- MinebeaMitsumi Inc. (FDA owner/operator no. 10055758)
- Registered address
- 1015 W 15th St, Auburn, IN 46706
- Contract listings
- 40 device listings, 32 product codes, first listed Oct 4, 2017
- 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 |
|---|---|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class II | Neurology | Contract manufacturing | Oct 5, 2017 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Mar 4, 2026 |
| HTZ | Instrument, Cutting, Orthopedic | Class I | General and plastic surgery | Contract manufacturing | Oct 5, 2017 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Oct 5, 2017 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Dec 8, 2022 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 8, 2022 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Dec 8, 2022 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | May 14, 2025 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 8, 2022 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 8, 2022 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Mar 4, 2026 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Oct 4, 2017 |
| MBB | Bone Cement, Antibiotic | Class II | Orthopedic | Contract manufacturing | Oct 3, 2019 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Oct 6, 2017 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Oct 5, 2017 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Oct 5, 2017 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Apr 20, 2021 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Jan 12, 2026 |
| PGM | Growing Rod System | Class II | Orthopedic | Contract manufacturing | Oct 4, 2017 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Class II | Orthopedic | Contract manufacturing | Sep 29, 2023 |