Identity
- Trade Name
- TrueLok FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- TL PLUS HALF RING 100MM STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TL PLUS HALF RING 100MM STERILE FDA UDI
Identifiers
- Catalog Number
- 99-56-11580 FDA UDI
- Primary DI / UDI-DI
- 18053340349321 FDA UDI
- 510(k) Number
- K941048 FDA UDI
- FDA Product Code
- LXT 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
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
- Lumen/Inner Diameter — 100 Millimeter FDA UDI
Category: External orthopaedic fixation system, single-use
TrueLok 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
K941048 also covers:
- ORTHOFIX — Orthofix, Inc.
- TRUELOK — Orthofix, Inc.
- TRUELOK — 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 95df4893-5fa9-44c6-8f19-b2b340523bba 37 fields · synced May 30, 2026