Cadence™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Cadence™ FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: Proximal Translation Block is a part of the Tibial Alignment guide, and is used to connect the Proximal Tibial Clamp with the tibial rod for proper positioning to the center of the patients distal tibial metaphysis. FDA UDI
Model / Reference: 10203006 FDA UDI
Description: Proximal Translation Block is a part of the Tibial Alignment guide, and is used to connect the Proximal Tibial Clamp with the tibial rod for proper positioning to the center of the patients distal tibial metaphysis. FDA UDI

Identifiers

Catalog Number: 10203006 FDA UDI
Primary DI / UDI-DI: 10381780240150 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

Cadence™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 16a29411-711c-4813-a6e7-46497dab1118 37 fields · synced Jun 1, 2026