CAVUX™ Cervical Cage-B 5mm

Primary DI
00852776006324
Brand
CAVUX™ Cervical Cage-B 5mm
Company
Providence Medical Technology, Inc.
Model
PD-31-201
Device description
CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122801000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122801000PROVIDENCE CERVICAL CAGEProvidence Medical Technology, Inc.2013-05-24ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852776006321PackageGS11In Commercial Distribution
00852776006324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085277600632110852776006321
00852776006324008527760063248527760063240852776006324

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cervical facet joint distractorA non-powered 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
Radiation Sterilization

Regulatory Flags#

DUNS number
969820245
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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
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
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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