Cleared Traditional

K221332 - OsteoCentric Spine MIS Pedicle Fastener System
(FDA 510(k) Clearance)

K221332 · OsteoCentric Technologies · Orthopedic

Jul 2022

Decision

80d

Days

Class 2

Risk

K221332 is an FDA 510(k) clearance for the OsteoCentric Spine MIS Pedicle Fastener System. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB).

Submitted by OsteoCentric Technologies (Logan, US). The FDA issued a Cleared decision on July 28, 2022, 80 days after receiving the submission on May 9, 2022.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion..

Submission Details

510(k) Number	K221332 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2022
Decision Date	July 28, 2022
Days to Decision	80 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.