Identity
- Trade Name
- RABEA 0° FDA UDI
- Generic Name
- Metallic 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, straight 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
- P041214 FDA UDI
- Primary DI / UDI-DI
- 04047844000021 FDA UDI
- 510(k) Number
- K082848 FDA UDI
- FDA Product Code
- ODP FDA UDIOVE FDA UDIMQP FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metallic spinal interbody fusion cage
Rabea 0° by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
- KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
- Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K082848 also covers:
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- RABEA 0° — SIGNUS Medizintechnik GmbH
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 5aa4c022-dcf1-4d55-80ca-defc9dd755cb 38 fields · synced Jun 6, 2026