Cleared Traditional

Pisces Spinal System

K203023 · Ortho Development Corporation · Orthopedic

Jul 2021

Decision

285d

Days

Class 2

Risk

About This 510(k) Submission

K203023 is an FDA 510(k) clearance for the Pisces Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on July 14, 2021, 285 days after receiving the submission on October 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K203023 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 2020
Decision Date	July 14, 2021
Days to Decision	285 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.