Identity
- Trade Name
- Hintermann Series H2 FDA UDI
- Generic Name
- Coated ankle tibia prosthesis FDA UDI
- Device Name
- H2 TIBIAL TRAY SIZE 4 - RIGHT (7MM) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- H2 TIBIAL TRAY SIZE 4 - RIGHT (7MM) FDA UDI
Identifiers
- Catalog Number
- 421804 FDA UDI
- Primary DI / UDI-DI
- B095421804 FDA UDI
- 510(k) Number
- K171004 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Coated ankle tibia prosthesis 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
No
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
MR Conditional FDA UDI
Category: Coated ankle tibia prosthesis
Hintermann Series H2 by Dt Medtech, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated ankle tibia prosthesis.
- Trabecular Metal® — Zimmer, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class II
- Kinos Axiom — Restor3D · Class II
- Kinos Axiom — Restor3D · Class II
- Kinos Axiom — Restor3D · Class II
- Kinos Axiom Total Ankle Replacement — Restor3D · Class II
- Hintermann Series H2 — Vilex, Inc. · Class II
- Hintermann Series H2 — Vilex, Inc. · Class II
Cleared under the same submission
K171004 also covers:
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
- Hintermann Series — Dt Medtech, LLC
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
- Dt Medtech, LLC
Sources (1)
- FDA UDI 41d08b51-db05-4748-9fdd-fd2b58403a7d 36 fields · synced Jun 1, 2026