Identity
- Trade Name
- SIDEKICK FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Model / Reference
- RR3520180 FDA UDI
Identifiers
- Catalog Number
- RR3520180 FDA UDI
- Primary DI / UDI-DI
- 00840420128416 FDA UDI
- FDA Product Code
- KTT FDA UDIJDW FDA UDI
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- 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
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 180 Millimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDI
Category: External orthopaedic fixation system, reusable
The SIDEKICK device is a comprehensive, reusable external orthopaedic fixation system designed to stabilize and treat long bones such as the femur, tibia, humerus, wrist, elbow, knee, hip, ankle, joint fusions, and limb lengthening. It typically consists of an external plastic or metallic fixator with various components including clamps, rods, rings, cams, bushings, collars, bolts, nuts, screwdrivers, wrenches, drills, and instrumentation such as screw drivers and wrenches. The device is used in orthopedic surgery to promote healing and support the treatment of fractures.
Similar devices
Also classified as External orthopaedic fixation system, reusable.
- HOFFMANN — Stryker Corp. · Class II
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
- PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
- TransFx™ — Zimmer, Inc. · Class I
- HOFFMANN — Stryker Corp. · Class II
- TENXOR — Stryker Corp. · Class II
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 |
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Manufacturer
- Manufacturer
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI fa15f080-adf9-48d5-95c6-7e54a7211a10 35 fields · synced Jul 11, 2026