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Kinos Axiom

FDA UDI

Class I (US FDA UDI)

by Restor3D

Identity

Trade Name
Kinos Axiom FDA UDI
Generic Name
Surgical saw blade, sagittal, single-use FDA UDI
Model / Reference
5801.4103 FDA UDI

Identifiers

Catalog Number
5801.4103 FDA UDI
Primary DI / UDI-DI
00850022178818 FDA UDI
FDA Product Code
GFA FDA UDI
GMDN Term
Surgical saw blade, sagittal, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical saw blade, sagittal, single-use

Kinos Axiom by Restor3D — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical saw blade, sagittal, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Restor3D

Sources (1)

  • FDA UDI 043fce6e-cd77-48e2-a1fe-c1c32004dd8a 33 fields · synced Jun 8, 2026