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HomeProvidence Medical Technology, Inc. › CORUS-LX Implant, 4mm

CORUS-LX Implant, 4mm

Providence Medical Technology, Inc. · Model DX-50-407 · UDI-DI 00852776006478

MRW Prescription
1
510(k) clearances
105
Adverse events
4
Recalls
100
Facilities

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.

Recalls

DateFirmReason
2021-04-27Medtronic Sofamor Danek USA, IncProduct is impacted by a thread profile defect due to a manufacturing issue.
2011-06-07Osteomed, LpTwo of the Implant Driver Assembly tips were reported to break during surgery.
2011-03-15Interventional Spine IncThis 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
2011-03-15Interventional Spine IncThis 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.