RABEA 0° PK081212

GUDID 04047844000526

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.

SIGNUS Medizintechnik GmbH

Polymeric spinal fusion cage, sterile
Primary Device ID04047844000526
NIH Device Record Key35999c67-9599-4b82-affa-c552267ebce0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRABEA 0°
Version Model NumberCervical cage, straight
Catalog NumberPK081212
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
GS104047844000526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2015-09-24

On-Brand Devices [RABEA 0°]

04047844000588The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000571The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000564The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000557The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000540The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000533The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000526The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000519The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000502The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000496The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000489The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000472The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000465The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000458The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000441The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000434The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000427The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000410The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000403The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000335The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000328The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000311The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000304The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000298The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000281The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000274The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000267The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000250The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000243The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000236The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000229The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000212The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000205The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000199The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000106The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000090The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000083The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000076The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000069The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000052The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000045The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000038The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000021The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000014The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec

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