RABEA 5° WK071414

GUDID 04047844000663

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 ID04047844000663
NIH Device Record Key00c9e281-d9a9-4a1a-913c-b7b2a2c5e740
Commercial Distribution StatusIn Commercial Distribution
Brand NameRABEA 5°
Version Model NumberCervical cage, angled
Catalog NumberWK071414
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
GS104047844000663 [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 5°]

04047844014059The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844014042The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000694The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000687The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000670The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000663The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000656The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000649The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000632The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000625The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000618The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000601The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000595The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000397The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000380The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000373The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000366The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000359The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000342The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000182The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000175The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000168The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000151The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000144The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000137The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000120The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec
04047844000113The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspec

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.