CORUS-LX LevelOne, 4mm

FDA UDI

Class U (US FDA UDI)

by Providence Medical Technology, Inc.

Identity

Trade Name: CORUS-LX LevelOne, 4mm FDA UDI
Generic Name: Internal spinal fixation procedure kit, single-use FDA UDI
Device Name: Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelOne” – which represents a combination of these devices. FDA UDI
Model / Reference: DX-50-409 FDA UDI
Description: Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelOne” – which represents a combination of these devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 00852776006546 FDA UDI
510(k) Number: K230840 FDA UDI
FDA Product Code: MRW FDA UDI
GMDN Term: Internal spinal fixation procedure kit, single-use FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Category: Internal spinal fixation procedure kit, single-use Implantable cervical facet joint distractor

CORUS-LX LevelOne, 4mm by Providence Medical Technology, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K230840 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 U	Pending data

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Manufacturer

Manufacturer: Providence Medical Technology, Inc.

Sources (1)

FDA UDI 0a938232-e4d5-4989-9e27-9b0096897f9c 34 fields · synced May 30, 2026