Identity
- Trade Name
- MJ-FLEX FDA UDI
- Generic Name
- Flexible intramedullary nail FDA UDI
- Device Name
- MJ-FLEX TI NAIL L400MM D2.5MM STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- MJ-FLEX TI NAIL L400MM D2.5MM STERILE FDA UDI
Identifiers
- Catalog Number
- 99-T662540 FDA UDI
- Primary DI / UDI-DI
- 18054242518846 FDA UDI
- 510(k) Number
- K172698 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Flexible intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 400 Millimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDI
Category: Flexible intramedullary nail
Mj-Flex by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible intramedullary nail.
- EPIX Distal Screw 65.0mm x 5mm — Epix Orthopaedics Inc. · Class II
- EPIX Distal Screw 75.0mm x 5mm — Epix Orthopaedics Inc. · Class II
- T2 — Stryker Corp. · Class II
- EPIX Assy, Long Nail 10mm x 460mm Right — Epix Orthopaedics Inc. · Class II
- T2 — Stryker Corp. · Class II
- EPIX Assy, Long Nail 10mm x 300mm Right — Epix Orthopaedics Inc. · Class II
- EPIX AntiRotation Device — Epix Orthopaedics Inc. · Class II
- EPIX Lag Screw 100mm x 11mm — Epix Orthopaedics Inc. · Class II
Cleared under the same submission
K172698 also covers:
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc.
- FRAGMENT FIXATION SYSTEM — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
- G-Beam Fusion Beaming System — Orthofix, Inc.
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
- Orthofix, Inc.
Sources (1)
- FDA UDI 91a105ed-0cac-4a3b-9fd8-6e5087c1ba6d 37 fields · synced Jun 8, 2026