Nubic

FDA UDI

Class II (US FDA UDI)

by SIGNUS Medizintechnik GmbH

Identity

Trade Name: NUBIC FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: 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. FDA UDI
Model / Reference: Cervical cage with strut FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: N051314 FDA UDI
Primary DI / UDI-DI: 04047844002025 FDA UDI
510(k) Number: K082848 FDA UDI
FDA Product Code: ODP FDA UDI
MQP FDA UDI
OVE FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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Single Use

Yes

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Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Category: Polymeric spinal interbody fusion cage

Intervertebral fusion devices, such as NUBIC and RABEA, are used to treat degenerative disc disease (DDD) by providing mechanical stability and facilitating bone fusion between two contiguous vertebral bodies. These devices come in various sizes and may be used with or without a connecting screw attachment to theSIGNUS TOSCA II anterior cervical plate.

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SIGNUS Medizintechnik GmbH

Sources (1)

FDA UDI 2eaa23d4-9c08-44ef-a67c-1ce73e5940d3 38 fields · synced Jul 10, 2026