Identity
- Trade Name
- TRUELOK SYSTEM FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- TRUELOK ELEVATE EXTERNAL FIXATOR FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TRUELOK ELEVATE EXTERNAL FIXATOR FDA UDI
Identifiers
- Catalog Number
- 50-2505 FDA UDI
- Primary DI / UDI-DI
- 18059015375909 FDA UDI
- 510(k) Number
- K242861 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
MR Unsafe FDA UDI
Category: External orthopaedic fixation system, single-use
Truelok System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
- Monkey Rings™ External Fixation System — Paragon 28 · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- RINGFIX — Stryker Corp. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
- External Fixation — Life Spine, Inc. · Class II
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
Cleared under the same submission
K242861 also covers:
- ORTHOFIX — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK SYSTEM — Orthofix, Inc.
- TRUELOK 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 52b157ec-e9aa-48e6-b3f9-31e222bd1326 36 fields · synced May 31, 2026