Identity
- Trade Name
- Salto Talaris® FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- Total Ankle Prosthesis Drill Bit, 3 mm Dia. X 135 mm FDA UDI
- Model / Reference
- LJV528T FDA UDI
- Description
- Total Ankle Prosthesis Drill Bit, 3 mm Dia. X 135 mm FDA UDI
Identifiers
- Catalog Number
- LJV528T FDA UDI
- Primary DI / UDI-DI
- 10381780510994 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Millimeter FDA UDILength — 135 Millimeter FDA UDI
Category: Joint prosthesis implantation kit, reusable
Salto Talaris® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, reusable.
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- IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
- Evolution — MicroPort Orthopedics Inc. · Class II
- GUARDIAN® — MicroPort Orthopedics Inc. · Class I
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- PROPHECY — MicroPort Orthopedics Inc. · Class II
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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 7dd9e165-2c5c-43d0-ad4b-c6301549c7bf 38 fields · synced Jun 1, 2026