Manta Ray TDF Spacer
K-Number: K220296 · 2023-02-03
ApplicantSeaSpine Orthopedics Corporation
Decision Date2023-02-03
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Manta Ray TDF Spacer is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2023-02-03 under approval number K220296. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Manta Ray TDF Spacer?
Manta Ray TDF Spacer is a medical device that received FDA 510(k) clearance on 2023-02-03. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K220296.
When was Manta Ray TDF Spacer approved by the FDA?
Manta Ray TDF Spacer received FDA 510(k) clearance on 2023-02-03, under approval number K220296.
What company makes Manta Ray TDF Spacer?
Manta Ray TDF Spacer is manufactured by SeaSpine Orthopedics Corporation.
What is the FDA product code for Manta Ray TDF Spacer?
The FDA product code for Manta Ray TDF Spacer is ODP.
Other Devices by SeaSpine Orthopedics Corporation
K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device
K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene
K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System
K161535SeaSpine® NewPort Spinal System
K160902Mariner Pedicle Screw System
K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical
Related Devices (Code: ODP)
K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.
K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education
K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company
K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.
K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd.
K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.