Identity
- Trade Name
- Hintermann Series FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Device Name
- Hintermann Series Tibial Rod FDA UDI
- Model / Reference
- HT-39001 FDA UDI
- Description
- Hintermann Series Tibial Rod FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731134080 FDA UDI
- 510(k) Number
- K240475 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation implant alignment tool
Hintermann Series by Vilex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation implant alignment tool.
- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
- EVOS — Smith & Nephew, Inc. · Class II
- “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) — Paonan Biotech Co., Ltd. · Class I
- U1™ Hip — UNITED ORTHOPEDIC CORP. · Class I
- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class I
- U-Motion II — UNITED ORTHOPEDIC CORP. · Class I
- Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
- Easyspine — Ldr Spine USA · Class I
Cleared under the same submission
K240475 also covers:
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, Inc.
- Hintermann Series — Vilex, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vilex, Inc.
Sources (1)
- FDA UDI 43ebdc1f-2a05-451c-bb26-83ab81840ffe 36 fields · synced Jun 8, 2026