FDA Registration
Active
🇺🇸 United States
UNITY TOOL, INC.
Reg #: 2133687
·
FEI: 3000206619
·
Expires 2026
Products
18
Proprietary Names
34
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- UNITY TOOL, INC.
- Registration Number
- 2133687
- FEI Number
- 3000206619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11660 TROY LN
- City
- Osseo
- State
- MN
- ZIP
- 55369
- Country
- US
Owner / Operator
- Firm Name
- UNITY TOOL, INC.
- Operator Number
- 9025123
- Address
- 11660 TROY LN., --
- City
- Maple Grove
- State
- MN
- Postal Code
- 55369
- Country
- US
- Correspondent
- MICHAEL R VAN ESSEN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Extractor | HWB | Class 1 | Orthopedic | No | 2014-12-30 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-09-25 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2014-04-03 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2014-04-03 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-12-20 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2012-11-07 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-22 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-12-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-12-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-12-20 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-22 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2012-11-07 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2014-04-03 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-12-30 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-12-26 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-03-19 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-22 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2013-12-20 |
Proprietary Names
Silhouette
Max
Puros Family ( Allogaft)
Symmetry
MAX
Mergence
ST360
Trinica ALP
BP/Lordotic
X-STOP Kyphon
28mm Reamer for Gleniod
32mm Reamer for Glenoid
Sequoia (Gen ll)
Pathfinder NXT
Trial Eccenter
Rossello Cavernotome Set
Brooks Dilator
Puros Family (Allogaft)
Dynesys
BAC/C
FlareHawk Interbody Fusion System
Compressor/Distractor-STA
Manual instruments intended for spinal surgery
Compressor/Distractor-LON
Pangea Threaded Remobiliz
Stem Holder Size 10 for Pr
MIS Threaded Remobilizer
Stem Holder Size 12 for Pr
Stem Holder Size 6 for Pr
Stem Holder Size 8 for Pr
Stem Holder Size 14 for Pr
Zimmer MIS
ARAS
InViSia
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)