restor3d Kinos Axiom PSR

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: restor3d Kinos Axiom PSR FDA UDI
Generic Name: Osteotomy guide, single-use FDA UDI
Device Name: Axiom PSR Bone Model FDA UDI
Model / Reference: 5831-910 FDA UDI
Description: Axiom PSR Bone Model FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097508955 FDA UDI
510(k) Number: K223326 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Osteotomy guide, single-use

restor3d Kinos Axiom PSR by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K223326 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Restor3D

Sources (1)

FDA UDI 96c65d40-88ad-4a0d-b306-0f9efa775d79 34 fields · synced May 30, 2026