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restor3d Disposable Instrument

FDA UDI

Class I (US FDA UDI)

by Restor3D

Identity

Trade Name
restor3d Disposable Instrument FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Cervical Trial Kit w Stop, Small-Large, 11-12mm Height FDA UDI
Model / Reference
4110-S014 FDA UDI
Description
Cervical Trial Kit w Stop, Small-Large, 11-12mm Height FDA UDI

Identifiers

Primary DI / UDI-DI
00840097507460 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use 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

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

Yes

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: Internal spinal fixation procedure kit, single-use

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

Similar devices

Also classified as Internal spinal fixation procedure kit, 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 20823fbc-d997-48fb-bc6c-b5b947688cac 33 fields · synced Jun 7, 2026