CORUS Navigation Access System

GUDID 00852776006638

The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation.

Providence Medical Technology, Inc.

Internal spinal fixation procedure kit, single-use
Primary Device ID00852776006638
NIH Device Record Key0abf6e04-5f82-4396-b0ab-9bde27901ecf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORUS Navigation Access System
Version Model NumberDX-01-160
Company DUNS969820245
Company NameProvidence Medical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852776006638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

Devices Manufactured by Providence Medical Technology, Inc.

00852776006447 - CAVUX CERVICAL CAGE-X, 5MM2024-11-21 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac
00852776006553 - ALLY Bone Screw-LX2024-11-21 The ALLY Bone Screw-LX is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fr
00852776006560 - CAVUX Cage-LX, 4mm2024-11-21 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine
00852776006584 - CORUS Spinal System-LX2024-11-21 CORUS™ Spinal System-LX is a sterile-packaged set of instruments for joint access, bone preparation, implant delivery, and bon
00852776006591 - CAVUX Facet Fixation System, 4mm2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX
00852776006607 - CAVUX Facet Fixation System, 5mm2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX
00852776006638 - CORUS Navigation Access System2024-11-21The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation.
00852776006638 - CORUS Navigation Access System2024-11-21 The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal Sys
00852776006492 - CAVUX Cervical Cage-X2024-11-01
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