Contract manufacturerINCIPIO DEVICES (Huntington, IN)IndianaGeneral and plastic surgeryNeurologyOrthopedicClass IClass II
INCIPIO DEVICES
Contract manufacturer · Huntington, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011015572 (openFDA record; or search FDA's registration database)
- FEI number
- 3011015572
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Incipio Devices (FDA owner/operator no. 10047511)
- Registered address
- 3650 West 200 North, Huntington, IN 46750
- Contract listings
- 35 device listings, 37 product codes, first listed Sep 26, 2014
- 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 |
|---|---|---|---|---|---|
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Apr 25, 2022 |
| FZY | Hammer, Surgical | Class I | General and plastic surgery | Contract manufacturing | Dec 11, 2024 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 17, 2019 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 14, 2016 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | May 16, 2025 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Sep 27, 2019 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jun 3, 2015 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Jul 8, 2019 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 14, 2016 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Oct 7, 2019 |
| HWM | Osteotome | Class I | General and plastic surgery | Contract manufacturing | Dec 11, 2024 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Feb 8, 2016 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Oct 7, 2019 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Oct 7, 2019 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Dec 11, 2019 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | Jan 5, 2022 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Feb 8, 2016 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Class II | Orthopedic | Contract manufacturing | Jan 7, 2020 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Jun 13, 2022 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jul 1, 2019 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 26, 2023 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Dec 17, 2019 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Dec 17, 2019 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 20, 2018 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 20, 2018 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jun 13, 2022 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Sep 26, 2014 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 7, 2020 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 20, 2017 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Dec 17, 2019 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Jul 1, 2019 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 17, 2019 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract manufacturing | Dec 20, 2018 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | Contract manufacturing | Dec 20, 2018 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Class II | Orthopedic | Contract manufacturing | Dec 12, 2024 |