CAVUX Facet Fixation System, 5mm

FDA UDI

Class U (US FDA UDI)

by Providence Medical Technology, Inc.

Identity

Trade Name: CAVUX Facet Fixation System, 5mm FDA UDI
Generic Name: Implantable cervical facet joint distractor FDA UDI
Device Name: CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. FDA UDI
Model / Reference: DX-31-404 FDA UDI
Description: CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. FDA UDI

Identifiers

Primary DI / UDI-DI: 00852776006607 FDA UDI
510(k) Number: K220951 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

CAVUX Facet Fixation System, 5mm 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

K220951 also covers:

CAVUX Facet Fixation System, 4mm — PROVIDENCE MEDICAL TECHNOLOGY, INC.

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 df996eec-7d1b-48d2-98a8-3121ff9829ed 34 fields · synced May 31, 2026