FDA.reportPublic FDA data

DTRAX Cervical Cage-B

Primary DI
20852776006069
Brand
DTRAX Cervical Cage-B
Company
Providence Medical Technology, Inc.
Model
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
2015-09-15
Public version status
Update
Distribution status
Not 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
20852776006069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085277600606920852776006069

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
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
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

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