Is this your brand? Sign in to claim ownership.
Sign in to claim this brandExotoe, LLC
US
Last updated May 23, 2026
What Exotoe, LLC makes
Exotoe, LLC manufactures non-adjustable orthopaedic bone staples designed for toe surgery, reusable surgical implant templates for precision bone alignment, and reusable soft-tissue manipulation forceps shaped like scissors for surgical procedures. These products are intended for use in foot and toe surgical applications, including fixation and tissue handling.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. All products are based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Exotoe, LLC manufacture?
Exotoe, LLC specializes in three primary device categories: non-adjustable orthopaedic bone staples for toe surgery, reusable surgical implant templates for precise bone alignment, and reusable soft-tissue manipulation forceps designed like scissors for surgical procedures. These devices are specifically engineered for foot and toe surgical applications, including fixation and tissue handling.
Where is Exotoe, LLC based, and what is its regulatory classification for its devices?
Exotoe, LLC is based in the United States. Its devices are classified as Class II under FDA regulations, which typically means they pose moderate risk and require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device.
Are Exotoe, LLC’s devices listed in any regulatory registries?
Yes, Exotoe, LLC’s devices are included in the FDA’s 510(k) database, which tracks premarket notifications for Class II devices, and the FDA’s Unique Device Identifier (UDI) system, which standardizes device labeling for tracking and traceability purposes.
How are Exotoe, LLC’s devices used in surgical procedures?
Exotoe’s devices are designed for foot and toe surgeries: the non-adjustable bone staples provide fixation for toe bones, the reusable surgical implant templates assist in aligning bones accurately during procedures, and the scissors-like forceps help manipulate soft tissues during surgery. Their reusable nature and specialized designs cater to precision and efficiency in these applications.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 081016089
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ExoToe | SZR001 | FDA UDI | Class II | Active |
| ExoToe | EX070 | FDA UDI | Class II | Active |
| ExoToe | EX060 | FDA UDI | Class II | Active |
| ExoToe | EX055 | FDA UDI | Class II | Active |
| ExoToe | EX075 | FDA UDI | Class II | Active |
| ExoToe | EX065 | FDA UDI | Class II | Active |
| ExoToe | FCP001 | FDA UDI | Class II | Active |
| ExoToe Staple | K172205 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.