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Shoreline Cervical Interbody RT System

by SeaSpine Orthopedics Corporation

510(k) K183083

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183083 Date14 Feb 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODP
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Shoreline Cervical Interbody RT System is an anterior cervical interbody system designed for spinal fusion procedures. It incorporates NanoMetalene® Technology, Reef Topography®, and an optional TruProfile® plating system to provide intraoperative flexibility and construct modularity.

The system is supplied as a sterile, single-use device and is intended for use in hospital or surgical center settings. It is available in various sizes, including configurations such as 16x14x7mm with a 7-degree angle, and is authorized under FDA 510(k) clearance K183083 with product code ODP.

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