Identity
- Trade Name
- Integra® XT FDA UDI
- Generic Name
- Fixed-bearing total ankle prosthesis FDA UDI
- Device Name
- Insert, Size 3, Right, TH19 FDA UDI
- Model / Reference
- LJU282T FDA UDI
- Description
- Insert, Size 3, Right, TH19 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780366218 FDA UDI
- 510(k) Number
- K153452 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Fixed-bearing total ankle 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
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
Category: Fixed-bearing total ankle prosthesis
Integra® XT by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-bearing total ankle prosthesis.
- INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- APEX 3D S Total Ankle Replacement System — Paragon 28 · Class II
- INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- QUANTUM — IN2BONES · Class II
- INFINITY™ EVERLAST™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
- XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class II
- Salto Talaris Total Ankle Prosthesis — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K153452 also covers:
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, Inc.
- Integra® XT — Ascension Orthopedics, 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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 74257a0f-f180-4b37-8e5b-a7b95a613c18 36 fields · synced May 31, 2026