Cleared Traditional

Reliance Cervical IBF System

K202266 · Reliance Medical Systems, LLC · Orthopedic

Mar 2022

Decision

595d

Days

Class 2

Risk

About This 510(k) Submission

K202266 is an FDA 510(k) clearance for the Reliance Cervical IBF System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on March 29, 2022, 595 days after receiving the submission on August 11, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K202266 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2020
Decision Date	March 29, 2022
Days to Decision	595 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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