510(k) K233414

Shoreline ACS Interbody System; Shoreline RT Interbody System by SeaSpine Orthopedics Corporation — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 28, 2023
Date Received: October 10, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by SeaSpine Orthopedics Corporation

K250908 — Virata Spinal Fixation System (June 18, 2025)
K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (April 2, 2025)
K242273 — Cove Putty, OsteoCove Putty (September 25, 2024)
K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral S (June 20, 2024)
K240566 — Reef L Interbody System; WaveForm L Interbody System (April 26, 2024)
K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System (April 19, 2024)
K233694 — Meridian Interbody System; WaveForm A Interbody System (January 12, 2024)
K232668 — Cove Strip, OsteoCove Strip (September 27, 2023)
K231030 — Cove Putty, OsteoCove Putty (September 14, 2023)
K230486 — Cove Strip (August 21, 2023)

Other clearances for product code OVE

K260038 — E3D-C Interbody System (February 4, 2026)
K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (December 22, 2025)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K250076 — Endeavor Stand-Alone Cervical IBF System (September 25, 2025)
K250540 — SABER-C System (August 8, 2025)
K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)