Identity
- Trade Name
- Hintermann Series H2 FDA UDI
- Generic Name
- Ankle prosthesis bearing FDA UDI
- Device Name
- H2 Vit E Poly Assembly, Sz 2, Left, 7mm, Neutral FDA UDI
- Model / Reference
- HT-38207 FDA UDI
- Description
- H2 Vit E Poly Assembly, Sz 2, Left, 7mm, Neutral FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731127495 FDA UDI
- 510(k) Number
- K240475 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Ankle prosthesis bearing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 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
No
FDA UDI
Radiation Sterilization FDA UDI
MR Conditional FDA UDI
Category: Ankle prosthesis bearing
Hintermann Series H2 by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ankle prosthesis bearing.
- Kinos Total Ankle Replacement — Restor3D · Class II
- Kinos Total Ankle Replacement — Restor3D · Class II
- Hintermann Series H3 — Dt Medtech, LLC · Class III
- Hintermann Series H2 — Dt Medtech, LLC · Class II
- Hintermann Series H2 — Dt Medtech, LLC · Class II
- Kinos Total Ankle Replacement — Restor3D · Class II
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class II
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Vilex, Inc.
Sources (1)
- FDA UDI 6e1eec23-6070-4d14-b1d3-5d6cdbb51947 37 fields · synced May 31, 2026