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Cadence Chamfer Cut Total Ankle System

FDA UDI

Class II (US FDA UDI)

by 3d Systems, Inc.

Identity

Trade Name
Cadence Chamfer Cut Total Ankle System FDA UDI
Generic Name
Osteotomy guide, single-use FDA UDI
Device Name
A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. FDA UDI
Model / Reference
Talus Cutting Guide FDA UDI
Description
A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes. FDA UDI

Identifiers

Primary DI / UDI-DI
00816847022712 FDA UDI
510(k) Number
K241326 FDA UDI
FDA Product Code
OYK FDA UDI
GMDN Term
Osteotomy guide, single-use 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

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Osteotomy guide, single-use

Cadence Chamfer Cut Total Ankle System by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteotomy guide, single-use.

Cleared under the same submission

K241326 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3d Systems, Inc.

Sources (1)

  • FDA UDI 3378f4ac-d901-4285-9d60-fbb0aabf89ca 34 fields · synced May 30, 2026