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FDA 510(k)

Shoreline Cervical Interbody RT System

K-Number: K183083 · 2019-02-14

ApplicantSeaSpine Orthopedics Corporation
Decision Date2019-02-14
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoreline Cervical Interbody RT System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2019-02-14 under approval number K183083. 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 Shoreline Cervical Interbody RT System?

Shoreline Cervical Interbody RT System is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K183083.

When was Shoreline Cervical Interbody RT System approved by the FDA?

Shoreline Cervical Interbody RT System received FDA 510(k) clearance on 2019-02-14, under approval number K183083.

What company makes Shoreline Cervical Interbody RT System?

Shoreline Cervical Interbody RT System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Shoreline Cervical Interbody RT System?

The FDA product code for Shoreline Cervical Interbody RT System is ODP.

Related Clinical Trials

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Other Devices by SeaSpine Orthopedics Corporation

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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.

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