DEVICE: ORTHROS (B030CP009700)

Device Identifier (DI) Information

ORTHROS
CP-009-70
In Commercial Distribution

CAMBER SPINE TECHNOLOGIES, LLC
B030CP009700
HIBCC

1
079625555 *Terms of Use
Ø5.5mm Anti-Rotation Curved Rod , 135 mm Lg.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polymeric spinal fusion cage, non-sterile A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation
KWQ Appliance, Fixation, Spinal Intervertebral Body
NKB Thoracolumbosacral Pedicle Screw System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 135 Millimeter
Outer Diameter: 5.5 Millimeter
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Device Record Status

2ff81bc0-3359-4dc5-b16d-b99f0d2a6913
March 29, 2018
2
January 13, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-866-643-0739
customerservice@cambermedtech.com
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