FDA.reportPublic FDA data

EZ-Track

Primary DI
00840314137739
Brand
EZ-Track
Company
NEXT ORTHOSURGICAL, INC.
Model
CJBB151308G
Catalog number
CJBB151308G
Device description
CERVICAL CAGE, DOMED, 15 X 13 X 8MM -6°
Published
2024-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K161608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161608000InterForm Cervical Interbody Cage SystemNext Orthosurgical2016-09-30ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314137739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314137739008403141377398403141377390840314137739

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle6degree
Height8Millimeter
Length13Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
046767258
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314141798Nex-D2CBCAJ-10000CBCAJ-100002024-09-16
00840314141804Nex-D2CBCBJ-10000CBCBJ-100002024-09-16
00840314165923Nex-D2CBFBJ-70140CBFBJ-701402024-09-05
00840314165930Nex-D2CBFBJ-70145CBFBJ-701452024-09-05
00840314165947Nex-D2CBFBJ-70150CBFBJ-701502024-09-05
00840314165954Nex-D2CBFBJ-78020CBFBJ-780202024-09-05
00840314165961Nex-D2CBFBJ-78025CBFBJ-780252024-09-05
00840314165978Nex-D2CBFBJ-78030CBFBJ-780302024-09-05
00840314165985Nex-D2CBFBJ-78035CBFBJ-780352024-09-05
00840314165992Nex-D2CBFBJ-78040CBFBJ-780402024-09-05
00840314166005Nex-D2CBFBJ-78045CBFBJ-780452024-09-05
00840314166012Nex-D2CBFBJ-78050CBFBJ-780502024-09-05
00840314166029Nex-D2CBFBJ-78055CBFBJ-780552024-09-05
00840314166036Nex-D2CBFBJ-78060CBFBJ-780602024-09-05
00840314166043Nex-D2CBFBJ-78065CBFBJ-780652024-09-05
00840314166050Nex-D2CBFBJ-78070CBFBJ-780702024-09-05
00840314166067Nex-D2CBFBJ-78075CBFBJ-780752024-09-05
00840314166074Nex-D2CBFBJ-78080CBFBJ-780802024-09-05
00840314166081Nex-D2CBFBJ-78085CBFBJ-780852024-09-05
00840314166098Nex-D2CBFBJ-78090CBFBJ-780902024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B084AC1141605070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141606070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141607070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141608070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141609070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141610070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141611070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1141612070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161805070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161806070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161807070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161808070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161809070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161810070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811000Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811040Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161811070Anterior Cervical IBFDKEOSODP2024-02-09
B084AC1161812000Anterior Cervical IBFDKEOSODP2024-02-09