NOVAL 10° NV101848

GUDID 04047844008379

The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

Polymeric spinal fusion cage, sterile
Primary Device ID04047844008379
NIH Device Record Key634592ac-d48c-4092-ba0f-b725ba7d5d20
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVAL 10°
Version Model NumberLumbar cage, angled
Catalog NumberNV101848
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
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

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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
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844008379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-22
Device Publish Date2015-09-24

On-Brand Devices [NOVAL 10°]

04047844009864The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844009857The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844009840The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844009833The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008379The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008362The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008355The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008348The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008331The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008324The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008317The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
04047844008300The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK
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