DEVICE: ORTHROS (B030CP009660)
Device Identifier (DI) Information
ORTHROS
CP-009-66
In Commercial Distribution
CAMBER SPINE TECHNOLOGIES, LLC
CP-009-66
In Commercial Distribution
CAMBER SPINE TECHNOLOGIES, LLC
Ø5.5mm Anti-Rotation Curved Rod , 115 mm Lg.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60762 | Polymeric spinal interbody fusion cage |
A 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.
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Active | true |
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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 115 Millimeter |
Outer Diameter: 5.5 Millimeter |
Device Record Status
537122bc-eb9a-4d12-ab5a-921b1df90ef6
February 24, 2020
4
January 13, 2017
February 24, 2020
4
January 13, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-866-643-0739
customerservice@cambermedtech.com
customerservice@cambermedtech.com