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restor3d Lumbar Instrument

FDA UDI

Class I (US FDA UDI)

by Restor3D

Identity

Trade Name
restor3d Lumbar Instrument FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Lumbar ALIF Trial, Large Footprint, 10mm Height, 12° FDA UDI
Model / Reference
5113-L1012 FDA UDI
Description
Lumbar ALIF Trial, Large Footprint, 10mm Height, 12° FDA UDI

Identifiers

Primary DI / UDI-DI
00840097507002 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

restor3d Lumbar Instrument by Restor3D — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Restor3D

Sources (1)

  • FDA UDI d86557ab-896b-4116-b0e0-83ba5860dfe6 33 fields · synced May 30, 2026