FDA.reportPublic FDA data

Diamondback

Primary DI
B014DB6530
Brand
Diamondback
Company
EMINENT SPINE LLC
Model
DB6530
Published
2017-02-13
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100377000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100377000DIAMONDBACK SPINAL SYSTEMEminent Spine2010-04-22MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B014DB6530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External spinal fixation systemAn assembly of devices designed to stabilize adjacent segments (i.e., vertebrae) of the spine. It typically consists of an external plastic and/or metallic fixator and other external and/or implantable components, such as plates, rods, pins, and bone screws; it may also include some instruments appropriate for attaching the implants (e.g., screw drivers, wrenches, drills). The system is intended for temporary immobilization of segments of the spine in patients with fractures of the thoracic and/or lumbar spine and also for some patients suffering of segmental instability or chronic back pain. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
022576742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B014DB100DiamondbackDB1002017-02-08
B014DB1030DiamondbackDB10302017-02-08
B014DB1035DiamondbackDB10352017-02-08
B014DB1040DiamondbackDB10402017-02-08
B014DB1045DiamondbackDB10452017-02-08
B014DB1050DiamondbackDB10502017-02-08
B014DB1055DiamondbackDB10552017-02-08
B014DB1060DiamondbackDB10602017-02-08
B014DB1065DiamondbackDB10652017-02-08
B014DB1070DiamondbackDB10702017-02-08
B014DB1075DiamondbackDB10752017-02-08
B014DB1080DiamondbackDB10802017-02-08
B014DB1085DiamondbackDB10852017-02-08
B014DB1090DiamondbackDB10902017-02-08
B014DB1095DiamondbackDB10952017-02-08
B014DB1100DiamondbackDB11002017-02-08
B014DB1110DiamondbackDB11102017-02-08
B014DB1120DiamondbackDB11202017-02-08
B014DB1130DiamondbackDB11302017-02-08
B014DB1140DiamondbackDB11402017-02-08

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Primary DI, Brand, Company table
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