FDA.reportPublic FDA data

ORTHROS

Primary DI
B030ORO85105R0
Brand
ORTHROS
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
ORO-85105R
Device description
Ø8.5mm polyaxial reduction pedicle screw , 105mm lg.
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B030ORO85105R0PrimaryHIBCC0

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
Length105Millimeter
Outer Diameter8.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-866-643-0739customerservice@cambermedtech.com

Regulatory Flags#

DUNS number
054205979
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
B030SPO1530020VARIANTSPO-153-0022022-11-25
B030TLP420WR0Alcantara™ Thoracolumbar PlatingTLP-420WR2025-08-01
B030TLP422WR0Alcantara™ Thoracolumbar PlatingTLP-422WR2025-08-01
B030TLP424WR0Alcantara™ Thoracolumbar PlatingTLP-424WR2025-08-01
B030TLP426WR0Alcantara™ Thoracolumbar PlatingTLP-426WR2025-08-01
B030TLP428WR0Alcantara™ Thoracolumbar PlatingTLP-428WR2025-08-01
B030TLP430WR0Alcantara™ Thoracolumbar PlatingTLP-430WR2025-08-01
B030TLP432WR0Alcantara™ Thoracolumbar PlatingTLP-432WR2025-08-01
B030TLP434WR0Alcantara™ Thoracolumbar PlatingTLP-434WR2025-08-01
B030TLP436WR0Alcantara™ Thoracolumbar PlatingTLP-436WR2025-08-01
B030TLP438WR0Alcantara™ Thoracolumbar PlatingTLP-438WR2025-08-01
B030TLP440WR0Alcantara™ Thoracolumbar PlatingTLP-440WR2025-08-01
B030TLP1000Alcantara Thoracolumbar PlatingTLP-100NA2024-07-18
B030TLP2180Alcantara Thoracolumbar PlatingTLP-218NA2024-07-18
B030TLP2200Alcantara Thoracolumbar PlatingTLP-220NA2024-07-18
B030TLP2220Alcantara Thoracolumbar PlatingTLP-222NA2024-07-18
B030TLP2240Alcantara Thoracolumbar PlatingTLP-224NA2024-07-18
B030TLP2260Alcantara Thoracolumbar PlatingTLP-226NA2024-07-18
B030TLP2280Alcantara Thoracolumbar PlatingTLP-228NA2024-07-18
B030TLP2350Alcantara Thoracolumbar PlatingTLP-235NA2024-07-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153143758XIA STAINLESS STEELStryker CorporationKWQ2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationKWQ2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045670XIA IStryker CorporationKWQ2014-12-08
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07613153045700XIA IStryker CorporationMNH2014-12-08
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07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationKWQ2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08