CORUS-LX Implant, 4mm

FDA UDI

Class U (US FDA UDI)

by Providence Medical Technology, Inc.

Identity

Trade Name: CORUS-LX Implant, 4mm FDA UDI
Generic Name: Implantable cervical facet joint distractor FDA UDI
Device Name: The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant. The device achieves facet fixation by spanning the facet interspace with points of fixation at each end of the construct. The device provides rigid fixation as an adjunct to fusion with the bone screw providing additional anchoring into cortical bone. The titanium constructs are offered in various footprints and heights and are manufactured from implant grade titanium alloy (6Al-4V Ti). CORUS-LX Implant is single-use only, provided sterile (gamma sterilized) with pre-attached, disposable, delivery handles. CORUSLX Implant should be implanted only using the CORUS™ Spinal System-LX. FDA UDI
Model / Reference: DX-50-407 FDA UDI
Description: The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant. The device achieves facet fixation by spanning the facet interspace with points of fixation at each end of the construct. The device provides rigid fixation as an adjunct to fusion with the bone screw providing additional anchoring into cortical bone. The titanium constructs are offered in various footprints and heights and are manufactured from implant grade titanium alloy (6Al-4V Ti). CORUS-LX Implant is single-use only, provided sterile (gamma sterilized) with pre-attached, disposable, delivery handles. CORUSLX Implant should be implanted only using the CORUS™ Spinal System-LX. FDA UDI

Identifiers

Primary DI / UDI-DI: 00852776006478 FDA UDI
510(k) Number: K230840 FDA UDI
FDA Product Code: MRW FDA UDI
GMDN Term: Implantable cervical facet joint distractor 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

Yes

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: Implantable cervical facet joint distractor

CORUS-LX Implant, 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 b8910390-5073-42da-807d-afcab85c2800 34 fields · synced May 30, 2026