FDA.reportPublic FDA data

CORUS™ Spinal System

Primary DI
00852776006430
Brand
CORUS™ Spinal System
Company
Providence Medical Technology, Inc.
Model
DX-22-100
Device description
The CORUS Spinal System instruments are used to access and prepare the posterior cervical spine for joint fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of allograft or autograft in patients with or without anterior or posterior instrumentation. It is recommended that commercially available autograft or allograft be used to aid fusion. Autograft or allograft material is not supplied as part of the system.
Published
2019-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190201000CORUS Spinal SystemProvidence Medical Technology, Inc.2019-03-08HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852776006437PackageGS11In Commercial Distribution
00852776006430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085277600643710852776006437
00852776006430008527760064308527760064300852776006430

GMDN Terms#

Term, Definition table
TermDefinition
Spinal endoscopic-access systemAn assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
415-301-3128jmandrusov@providencemt.com
(415) 923-9376cfick@providencemt.com

Regulatory Flags#

DUNS number
969820245
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852776006690CORUS NAVIGATION ACCESS SYSTEM-GLX DX-01-1802025-11-03
00852776006478CORUS-LX Implant, 4mmDX-50-4072025-08-13
00852776006539CORUS-LX Implant, 5mmDX-50-4082025-08-13
00852776006546CORUS-LX LevelOne, 4mmDX-50-4092025-08-13
00852776006577CAVUX Cage-LX, 5mmPD-31-2062025-07-08
00852776006010CAVUX Cervical Cage-TPD-31-100PD-31-1002015-09-02
00852776006270CAVUX™ Cervical Cage-L 8x12x15mm 7 deg PD-31-602PD-31-6022016-10-14
00852776006324CAVUX™ Cervical Cage-B 5mmPD-31-2012016-09-26
00852776006454CORUS™ Allograft Delivery Instrument PD-10-4002019-07-24
00852776006386CAVUX™ Cervical Cage SEPD-31-220 2019-07-23
00852776006423CAVUX™ Cervical Cage SBPD-31-202 2019-07-23
00852776006003CAVUX Cervical Cage-BPD-31-200PD-31-2002015-09-02
00852776006089DTRAX® Spinal SystemDX-22-100DX-22-1002017-06-27
00852776006508CORUS Spinal System-XDX-22-300DX-22-3002020-06-12
00852776006492CAVUX Cervical Cage-XPD-31-203PD-31-2032020-06-12
00852776006256CAVUX™ Cervical Cage-L 6x12x15mm 7 deg PD-31-600PD-31-6002016-10-14
00852776006263CAVUX™ Cervical Cage-L 7x12x15mm 7 degPD-31-601PD-31-6012016-10-14
00852776006287CAVUX™ Cervical Cage-L 9x12x15 mm 7 deg PD-31-603PD-31-6032016-10-14
00852776006294CAVUX™ Cervical Cage-L 10x12x15mm 7 deg PD-31-604PD-31-6042016-10-14
00852776006348CAVUX™ Cervical Cage-L 7x14x17mmPD-31-610PD-31-6102017-06-28

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Primary DI, Brand, Company table
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04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
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