FDA.reportPublic FDA data

CAVUX Facet Fixation System, 4mm

Primary DI
00852776006591
Brand
CAVUX Facet Fixation System, 4mm
Company
Providence Medical Technology, Inc.
Model
DX-31-403
Device 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.
Published
2024-11-13
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

Product Codes#

Code, Name table
CodeName
MRWSystem, Facet Screw Spinal Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220951000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220951000PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc.2022-12-09MRW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852776006591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852776006591008527760065918527760065910852776006591

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cervical facet joint distractorA sterile wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation.

Sterilization Methods#

Method table
Method

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
00852776006249CORUS PCSS 3D-T Implant, 4mmDX-50-4212026-10-26
00852776006713CORUS Navigation Access System-G2LXDX-01-1952026-10-26
00852776006744CORUS PCSS 3D-T Implant, 5mmDX-50-4222026-10-26
00852776006751CORUS PCSS 3D-T LevelOne, 4mmDX-50-4232026-10-26
00852776006614CORUS PCSS 3D LevelOne, 4mmDX-50-4132026-09-30
00852776006621CORUS PCSS 3D Implant, 4mmDX-50-4112026-09-30
00852776006706CORUS PCSS 3D Implant, 5mmDX-50-4122026-09-30
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
00852776006430CORUS™ Spinal SystemDX-22-1002019-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852776006249CORUS PCSS 3D-T Implant, 4mmProvidence Medical Technology, Inc.MRW2026-10-26
00852776006744CORUS PCSS 3D-T Implant, 5mmProvidence Medical Technology, Inc.MRW2026-10-26
00852776006751CORUS PCSS 3D-T LevelOne, 4mmProvidence Medical Technology, Inc.MRW2026-10-26
00888867614543Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614550Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614567Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614574Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614581Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614598Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614604Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614611Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614628Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614635Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614642Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614659Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614666Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614673Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614680Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614697Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614703Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614710Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614727Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614734Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614741Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614758Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614765Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614772Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614789Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614796Arthrex®ARTHREX, INC.MRW2026-10-07
00888867614802Arthrex®ARTHREX, INC.MRW2026-10-07