FDA.reportPublic FDA data

CAVUX Cervical Cage-B

Primary DI
00852776006003
Brand
CAVUX Cervical Cage-B
Company
Providence Medical Technology, Inc.
Model
PD-31-200
Catalog number
PD-31-200
Device description
The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Published
2015-09-02
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
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
00852776006003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852776006003008527760060038527760060030852776006003

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
Lot or batch
true
Manufacturing date on label
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
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
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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00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.ODP2026-06-05
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