Identity
- Trade Name
- TRUELOK SYSTEM FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- TRUELOK ELEVATE TEMPLATE STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TRUELOK ELEVATE TEMPLATE STERILE FDA UDI
Identifiers
- Catalog Number
- 99-50-2506 FDA UDI
- Primary DI / UDI-DI
- 18059015375985 FDA UDI
- 510(k) Number
- K242861 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Surgical implant template, 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Truelok System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 962c0212-436b-45d0-8ced-acc1fd65be0d 36 fields · synced May 30, 2026