DEVICE: MOBIS XL 0° (04047844001714)

Device Identifier (DI) Information

MOBIS XL 0°
Lumbar cage, straight
In Commercial Distribution
B121132
SIGNUS Medizintechnik GmbH
04047844001714
GS1

1
344203948 *Terms of Use
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MQP Spinal Vertebral Body Replacement Device
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111792 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 12x11x32mm
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Device Record Status

a661b1f6-3aeb-4843-865b-172999d2b329
October 11, 2023
6
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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
Yes
Yes
No CLOSE

Customer Contact

[?]
+49602391660
info@signus.com
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