Contract manufacturerUNITY TOOL, INC. (Osseo, MN)MinnesotaGeneral and plastic surgeryOrthopedicGastroenterology and urologyClass IClass IIClass III
UNITY TOOL, INC.
Contract manufacturer · Osseo, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2133687 (openFDA record; or search FDA's registration database)
- FEI number
- 3000206619
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- UNITY TOOL, INC. (FDA owner/operator no. 9025123)
- Registered address
- 11660 TROY LN, Osseo, MN 55369
- Contract listings
- 20 device listings, 18 product codes, first listed Nov 7, 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 |
|---|---|---|---|---|---|
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | Apr 3, 2014 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Jan 22, 2013 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Apr 3, 2014 |
| GFC | Driver, Surgical, Pin | Class I | General and plastic surgery | Contract manufacturing | Dec 20, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Apr 3, 2014 |
| HTO | Reamer | Class I | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Dec 30, 2014 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 22, 2013 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Dec 20, 2013 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Mar 19, 2013 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Class I | Gastroenterology and urology | Contract manufacturing | Nov 7, 2012 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Dec 30, 2014 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Dec 26, 2012 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 26, 2012 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Mar 19, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Mar 19, 2013 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Mar 19, 2013 |
| NQO | Prosthesis, Spinous Process Spacer/Plate | Class III | Orthopedic | Contract manufacturing | Nov 7, 2012 |