FDA.reportPublic FDA data

EZ-Track

Primary DI
00840314133045
Brand
EZ-Track
Company
NEXT ORTHOSURGICAL, INC.
Model
CAFB552415H
Catalog number
CAFB552415H
Device description
LLIF INTERBODY CAGE, 24 X 55 X 15MM -7°
Published
2024-09-11
Public version status
New
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131082000INTERFORM INTERBODY CAGE SYSTEMNext Orthosurgical2013-08-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314133045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314133045008403141330458403141330450840314133045

GMDN Terms#

Term, Definition table
TermDefinition
Visual input/output switching adaptorA mains electricity (AC-powered) device intended to be used to manage the distribution of four digital visual interface (DVI) video sources to four DVI peripheral devices. It is typically used during endoscopic, microsurgical or open surgical procedures in an operating room (OR) or clinic to switch DVI-D (DVI-digital) compatible video signals from video capture sources (e.g., endoscope-/microscope-cameras, multi-purpose digital medical camera, surgical video camera, ultrasonic devices) to output devices (e.g., monitors, transmitters or encoding devices).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Height15Millimeter
Length55Millimeter
Width24Millimeter

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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