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External Fixator Trocar and handle small
FDA UDIClass II (US FDA UDI)
by Gexfix Sa
Identity
- Trade Name
- External Fixator Trocar and handle small FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- Reusable external orthopaedic fixation system instrument intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated, reusable device. FDA UDI
- Model / Reference
- 5025-2000 FDA UDI
- Description
- Reusable external orthopaedic fixation system instrument intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated, reusable device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640136270507 FDA UDI
- 510(k) Number
- K052605 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable 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
No
FDA UDI
Implantable
No
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: General external orthopaedic fixation system implantation kit, reusable
External Fixator Trocar and handle small by Gexfix Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gexfix Sa
Sources (1)
- FDA UDI 6f328dda-5338-4c04-ae39-795ec8a24dfd 34 fields · synced May 31, 2026