Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Shoreline ACS (Anterior Cervical System)

K-Number: K201646 · 2020-09-14

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-09-14
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoreline ACS (Anterior Cervical System) is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K201646. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shoreline ACS (Anterior Cervical System)?

Shoreline ACS (Anterior Cervical System) is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K201646.

When did Shoreline ACS (Anterior Cervical System) receive FDA 510(k) clearance?

Shoreline ACS (Anterior Cervical System) received FDA 510(k) clearance on 2020-09-14, under 510(k) number K201646.

Who is the listed applicant for Shoreline ACS (Anterior Cervical System)?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shoreline ACS (Anterior Cervical System)?

The FDA product code for Shoreline ACS (Anterior Cervical System) is OVE.

Other records listing SeaSpine Orthopedics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SyK250908Virata Spinal Fixation SystemK243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsK242273Cove Putty, OsteoCove PuttyK241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody SystemK240566Reef L Interbody System; WaveForm L Interbody System

View all 67 devices →

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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.

↑