# K090861: Mambo, Model CS 18XX-XX

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: May 21, 2010 after 417 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922087 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052292: Spider Cervical Plating (SCP) System, X-Spine Systems, Inc. (2005) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 1.
- K000486: Abc Cervical Plating System, Aesculap, Inc. (2000) Summary page 1.

## Indications for use
mambo TM is intended for anterior operative stabilization of the cervical spine, C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies Spondylolisthesis Trauma (i.e., fracture or dislocation) Spinal stenosis Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) Tumor Pseudoarthrosis Failed previous fusion Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K090861
Methodology: https://510kreport.com/methodology