# K200224: SEA-LINK Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Indius Medical Technologies Pvt., Ltd.
- Decided: Mar 24, 2020 after 55 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: 4 generations back to K953730 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070775: Modification to: Providence Anterior Cervical Plate System, Globus Medical, Inc. (2007) Summary page 5.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 5.

## Cited in the summary but kept off the family tree
- K134104: Terrace™ Anterior Cervical Plate System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Indications for use
The SEA-LINK Anterior Cervical Plate System is intended for temporary stabilization of the anterior cervical spine (C2-C7) during the development of cervical spinal fusion achieved through ACDF (Anterior Cervical Discectomy & Fusion) or corpectomy in patients with: •Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) •Trauma (including fractures) •Tumors •Deformity defined as kyphosis, lordosis or scoliosis •Pseudarthrosis •Failed Previous Fusions •Spondylolisthesis •Spinal Stenosis

Source page: https://510kreport.com/device/K200224
Methodology: https://510kreport.com/methodology