# K220296: Manta Ray TDF Spacer

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Feb 3, 2023 after 366 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 551 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 553 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183083: Shoreline Cervical Interbody RT System, SeaSpine Orthopedics Corporation (2019) Summary page 4.
- K212904: SeaSpine WaveForm C Interbody System, SeaSpine Orthopedics Corporation (2021) Summary page 4.
- K101363: VU Cpod Intervertebral Bodu Fusion Device, Musculoskeletal Clinical Regulatory Advisers (2010) Summary page 4.
- K151496: Latitude-C Cervical Interbody Spacer System, Degen Medical (2015) Summary page 4.

## Most influential descendants
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own

## Indications for use
The Manta Ray TDF Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The Manta Ray TDF Spacer is intended for use with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Source page: https://510kreport.com/device/K220296
Methodology: https://510kreport.com/methodology