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Kinos Aeros Instrumentation

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name
Kinos Aeros Instrumentation FDA UDI
Generic Name
Coated ankle tibia prosthesis FDA UDI
Device Name
Threaded Heel Rod FDA UDI
Model / Reference
5871-1157 FDA UDI
Description
Threaded Heel Rod FDA UDI

Identifiers

Primary DI / UDI-DI
00840097516134 FDA UDI
510(k) Number
K242868 FDA UDI
FDA Product Code
HSN FDA UDI
GMDN Term
Coated ankle tibia prosthesis 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Coated ankle tibia prosthesis

Kinos Aeros Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated ankle tibia prosthesis.

Cleared under the same submission

K242868 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Restor3D

Sources (1)

  • FDA UDI 611e329f-52fc-4e8c-9b92-771973ffb5c9 34 fields · synced May 30, 2026