Identity
- Trade Name
- ORTHOFIX FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- TRUELOK ELEVATE DRILL POSITIONING GUIDE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TRUELOK ELEVATE DRILL POSITIONING GUIDE FDA UDI
Identifiers
- Catalog Number
- 50-2509 FDA UDI
- Primary DI / UDI-DI
- 18059015376487 FDA UDI
- 510(k) Number
- K242861 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Surgical drill guide, 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical drill guide, reusable
Orthofix by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical drill guide, reusable.
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Cleared under the same submission
K242861 also covers:
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI a909fc62-ca0b-4a9d-91c6-ca266fe85d38 35 fields · synced Jun 8, 2026