# K200863: Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: Apr 28, 2020 after 27 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K003155 (2001). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132504: Tiger Occipital-Cervical-Thoracic Spinal Fixation System, Corelink, LLC (2013) Summary page 5.
- K153631: Zimmer Virage OCT Spinal Fixation System, Zimmer Spine, Inc. (2016) Summary page 5.

## Indications for use
The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Tiger Occipital-Cervical-Thoracic Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Tiger Occipital-Cervical-Thoracic Spinal Fixation System may be connected to the components in the Tiger Spine System using the side by side and end to end rod to rod connectors.

Source page: https://510kreport.com/device/K200863
Methodology: https://510kreport.com/methodology