MOBIS XL 0° BT091132

GUDID 04047844001868

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™).

SIGNUS Medizintechnik GmbH

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device ID04047844001868
NIH Device Record Key345b376a-c367-45e1-9b3f-3a2eb05a6b17
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOBIS XL 0°
Version Model NumberLumbar cage, straight
Catalog NumberBT091132
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844001868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSpinal Vertebral Body Replacement Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-10-11
Device Publish Date2015-09-24

On-Brand Devices [MOBIS XL 0°]

04047844002001The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001981The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001967The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001943The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001929The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001905The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001882The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001868The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001844The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001820The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001806The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001790The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001776The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001752The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001738The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001714The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001691The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001677The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001653The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001639The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001615The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
04047844001592The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame wi
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.