Identity
- Trade Name
- Vantage FDA UDI
- Generic Name
- Ankle prosthesis trial, reusable FDA UDI
- Device Name
- A/P SIZING TOOL FDA UDI
- Model / Reference
- 351-10-15 FDA UDI
- Description
- A/P SIZING TOOL FDA UDI
Identifiers
- Catalog Number
- 351-10-15 FDA UDI
- Primary DI / UDI-DI
- 10885862292841 FDA UDI
- 510(k) Number
- K152217 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Ankle prosthesis trial, reusable 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ankle prosthesis trial, reusable
Vantage by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ankle prosthesis trial, reusable.
- Hintermann Series — Dt Medtech, LLC · Class I
- Cadence™ — Ascension Orthopedics, Inc. · Class I
- INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Cadence™ — Ascension Orthopedics, Inc. · Class I
- Cadence™ — Ascension Orthopedics, Inc. · Class I
- XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class I
- Incompass Total Ankle System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Cleared under the same submission
K152217 also covers:
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
- Exactech, Inc.
Sources (1)
- FDA UDI be51ee87-2a85-40d6-b32e-deeece9aeb1f 35 fields · synced Jun 8, 2026