# K080690: Manta Ray Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Apr 25, 2008 after 45 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926453 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K010466: Tether Acfs, Theken Surgical,Llc (2001) Summary page 1.

## Recalls of this device
- Jan 10, 2011 · Not classified · Z-2197-2011: Based upon the results of the firm's literature review, they determined that the Package Insert (Information for Use) and information in the Surgical Technique should be revised to include additional 
- Jul 29, 2010 · Not classified · Z-0087-2011: The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedu

## Indications for use
The Manta Ray TM ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Trauma (i.e. fracture/dislocation) Tumor Spinal stenosis Deformity (i.e. scoliosis, kyphosis and/or lordosis) Pseudoarthrosis Failed previous fusion

Source page: https://510kreport.com/device/K080690
Methodology: https://510kreport.com/methodology