FDA.reportPublic FDA data

CAVUX™ Cervical Cage-B 5mm

Primary DI
10852776006321
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
OTC
false
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
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
969820245
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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

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