RABEA 0° P051214

GUDID 04047844000038

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

Metallic spinal interbody fusion cage

Primary Device ID	04047844000038
NIH Device Record Key	d5e68255-9288-4c0a-a8be-f6069d353787
Commercial Distribution Status	In Commercial Distribution
Brand Name	RABEA 0°
Version Model Number	Cervical cage, straight
Catalog Number	P051214
Company DUNS	344203948
Company Name	SIGNUS Medizintechnik GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+49602391660
Email	info@signus.com

Device Dimensions

Device Size Text, specify

Operating and Storage Conditions

Storage Environment Temperature

Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844000038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K082848

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2020-02-24
Device Publish Date	2015-09-24

On-Brand Devices [RABEA 0°]

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