Salto Talaris Total Ankle Prosthesis

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: Salto Talaris Total Ankle Prosthesis FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: SALTO TALARIS. PIN PULLER FDA UDI
Model / Reference: MJU359T FDA UDI
Description: SALTO TALARIS. PIN PULLER FDA UDI

Identifiers

Catalog Number: MJU359T FDA UDI
Primary DI / UDI-DI: 00885556832806 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Joint prosthesis implantation kit, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

Salto Talaris Total Ankle Prosthesis by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Initia Total Hip System — Kyocera Corporation · Class II
PROPHECY — MicroPort Orthopedics Inc. · Class II
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
GLADIATOR® — MicroPort Orthopedics Inc. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 10806781-2a99-4a9a-82e7-5f42add1ef08 35 fields · synced Jun 8, 2026