Identity
- Trade Name
- Hintermann Series FDA UDI
- Generic Name
- Ankle prosthesis trial, reusable FDA UDI
- Device Name
- Flat Cut Talar Trial, Right, Size 5 Instrument FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Flat Cut Talar Trial, Right, Size 5 Instrument FDA UDI
Identifiers
- Catalog Number
- 319794 FDA UDI
- Primary DI / UDI-DI
- B095319794 FDA UDI
- 510(k) Number
- K171004 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Ankle prosthesis trial, reusable 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ankle prosthesis trial, reusable
A comprehensive medical device directory listing the Hintermann Series ankle prosthesis trial, reusable device. Learn more about its features, regulatory compliance, and distribution status.
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Also classified as Ankle prosthesis trial, reusable.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Dt Medtech, LLC
Sources (1)
- FDA UDI bc7a4a9d-8301-4446-ae02-3a16174aedc2 36 fields · synced Jul 22, 2026