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RABEA 5°

SIGNUS Medizintechnik GmbH · Model Cervical cage, angled · UDI-DI 04047844000397

ODP MQP OVE Prescription

510(k) clearances

1,117

Adverse events (3 deaths)

Recalls

344

Facilities

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.

Recalls

Date	Firm	Reason
2025-11-03	Orthofix U.S. LLC	Labeling contains claims that are not consistently present.
2025-11-03	Orthofix U.S. LLC	Labeling contains claims that are not consistently present.
2023-07-12	Medicrea International	There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12	Medicrea International	There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12	Medicrea International	There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2020-09-30	XTANT Medical	Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
2013-10-07	RTI Surgical, Inc.	As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ
2013-02-05	SpineNet	The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to
2012-06-15	Exactech, Inc.	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inter
2011-09-23	Synthes USA (HQ), Inc.	LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.