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CAVUX Facet Fixation System, 5mm

Providence Medical Technology, Inc. · Model DX-31-404 · UDI-DI 00852776006607

MRW Prescription

510(k) clearances

105

Adverse events

Recalls

100

Facilities

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.

Recalls

Date	Firm	Reason
2021-04-27	Medtronic Sofamor Danek USA, Inc	Product is impacted by a thread profile defect due to a manufacturing issue.
2011-06-07	Osteomed, Lp	Two of the Implant Driver Assembly tips were reported to break during surgery.
2011-03-15	Interventional Spine Inc	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra
2011-03-15	Interventional Spine Inc	This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver ra

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.