Identity
- Trade Name
- Smart Correction FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- Dual Hole 2/3 Ring, 135mm ID, Aluminum, Blue, Non-Sterile FDA UDI
- Model / Reference
- 31-700-13528BA-0 FDA UDI
- Description
- Dual Hole 2/3 Ring, 135mm ID, Aluminum, Blue, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- 31-700-13528BA-0 FDA UDI
- Primary DI / UDI-DI
- B5623170013528BA00 FDA UDI
- 510(k) Number
- K221366 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Smart Correction is an advanced external orthopaedic fixation system designed to stabilize fractured bones and promote optimal treatment and healing. This single-use device consists of a combination of external plastic and/or metallic fixators, clamps, rods, rings, pins, bolts, and nuts, along with reusable instrumentation such as wrenches and depth gauges. It is primarily used for the treatment of long bones like the femur, tibia, and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wishbone Medical Inc.
Sources (1)
- FDA UDI 80fb5719-023b-40f9-babd-c0d218070d50 36 fields · synced Jun 26, 2026