Class Class II
Manta Ray TDF Spacer (K220296)
Description
Manta Ray TDF Spacer by SeaSpine Orthopedics Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220296
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeODP
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220296
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Manta Ray TDF Spacer (K220296) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212904 | SeaSpine WaveForm C Interbody System | SeaSpine Orthopedics Corporation | 2021 |
| K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | 2019 |
| K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015 |
| K101363 | VU CPOD INTERVERTEBRAL BODU FUSION DEVICE | Musculoskeletal Clinical Regulatory... | 2010 |
Trace the full predicate network for K220296
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.