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Cadence®

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
CADENCE® FDA UDI
Generic Name
Fixed-bearing total ankle prosthesis FDA UDI
Device Name
Cadence®Total Ankle System, Flat Cut Talar Dome, Size 5, Left FDA UDI
Model / Reference
10208215 FDA UDI
Description
Cadence®Total Ankle System, Flat Cut Talar Dome, Size 5, Left FDA UDI

Identifiers

Catalog Number
10208215 FDA UDI
Primary DI / UDI-DI
10381780527206 FDA UDI
510(k) Number
K201507 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
Not 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

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K201507 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 545be77c-e28c-478f-92f5-114c557365bd 38 fields · synced May 30, 2026