Identity
- Trade Name
- TRUELOK FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- TRUELOK FOOT LEG ALIGNMENT SUPPORT PACK OF 3 STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TRUELOK FOOT LEG ALIGNMENT SUPPORT PACK OF 3 STERILE FDA UDI
Identifiers
- Catalog Number
- 99-56-24200M FDA UDI
- Primary DI / UDI-DI
- 18052469472880 FDA UDI
- FDA Product Code
- KQZ FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.5890 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External orthopaedic fixation system, single-use
Truelok by Orthofix, Inc. — Class I — 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
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- 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
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 I | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 60f8c657-746e-405f-b168-6ec79da3bde4 34 fields · synced May 30, 2026