Cleared Special

SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a?POD-L NanoMetalene, SeaSpine Vu e?POD System, SeaSpine Vu a?POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System

K210497 · SeaSpine Orthopedics Corporation · Orthopedic

Jul 2021

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K210497 is an FDA 510(k) clearance for the SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a?POD-L NanoMetalene, SeaSpine Vu e?POD System, SeaSpine Vu a?POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on July 7, 2021, 135 days after receiving the submission on February 22, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K210497 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2021
Decision Date	July 07, 2021
Days to Decision	135 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.