FDA.reportPublic FDA data

Orthros

Primary DI
B030ORT7565CR0
Brand
Orthros
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
ORT-7565CR
Device description
Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 65mm Lg.
Published
2019-01-23
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
NKBThoracolumbosacral Pedicle Screw System

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133366000ORTHROS POSTERIOR STABILIZATION SYSTEMCamber Spine2014-04-08NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B030ORT7565CR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800043965050N/ATDM Co., Ltd.KWQ2026-06-05
08800043965067N/ATDM Co., Ltd.KWQ2026-06-05
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08800043965098N/ATDM Co., Ltd.KWQ2026-06-05
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08800043965210N/ATDM Co., Ltd.KWQ2026-06-05
08800043965227N/ATDM Co., Ltd.KWQ2026-06-05
08800043965234N/ATDM Co., Ltd.KWQ2026-06-05
08800043965241N/ATDM Co., Ltd.KWQ2026-06-05
08800043965258N/ATDM Co., Ltd.KWQ2026-06-05
08800043965265N/ATDM Co., Ltd.KWQ2026-06-05
08800043965272N/ATDM Co., Ltd.KWQ2026-06-05
08800043965289N/ATDM Co., Ltd.KWQ2026-06-05
08800043965296N/ATDM Co., Ltd.KWQ2026-06-05
08800043965302N/ATDM Co., Ltd.KWQ2026-06-05