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External Fixator Lengthening / compression tube small
FDA UDIClass II (US FDA UDI)
by Gexfix Sa
Identity
- Trade Name
- External Fixator Lengthening / compression tube small FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use. FDA UDI
- Model / Reference
- 1010-1100 FDA UDI
- Description
- Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640136270248 FDA UDI
- 510(k) Number
- K052605 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: External orthopaedic fixation system, single-use
External Fixator Lengthening / compression tube small by Gexfix Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
- TRUELOK EVO — Orthofix, Inc. · Class II
- Monkey Rings™ External Fixation System — Paragon 28 · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
Cleared under the same submission
K052605 also covers:
- External Fixator Carbon Ring Ø 160 — GEXFIX SA
- External Fixator Carbon Tube 15x150 — GEXFIX SA
- External Fixator Carbon ring Ø 200 — GEXFIX SA
- External Fixator Carbon rod 9x110 — GEXFIX SA
- External Fixator Carbon rod 9x150 — GEXFIX SA
- External Fixator Carbon rod 9x200 — GEXFIX SA
- External Fixator Carbon rod 9x70 — GEXFIX SA
- External Fixator Carbon rod 9x90 — GEXFIX SA
- External Fixator Carbon tube 15x100 — GEXFIX SA
- External Fixator Carbon tube 15x125 — GEXFIX SA
- External Fixator Carbon tube 15x200 — GEXFIX SA
- External Fixator Carbon tube 15x250 — GEXFIX SA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
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
- Gexfix Sa
Sources (1)
- FDA UDI 50e4893a-0d32-4c71-8119-7b4ed229a01e 34 fields · synced May 30, 2026