Nubic and Rabea Devices
510(k) K082848
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082848 | Date24 Jul 2009 | StatusActive |
Official records
- FDA 510(k) database K082848
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ODP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The NUBIC and RABEA devices are rectangular frame implants with open upper and lower aspects featuring surface spikes that assist in positive anchorage and seating between superior and inferior vertebral bodies. These devices are designed for spinal surgery applications and are available in various sizes to accommodate individual pathology needs.
The devices are supplied by SIGNUS Medizintechnik GmbH and have received FDA 510(k) clearance with a K number of K082848. They are classified under product code ODP and were reviewed by the Orthopedic advisory committee. The devices are intended for use in spinal surgical procedures, though specific sterility and single-use or reusable status information is not provided in the available data.