Cleared Traditional

TrellOss?-L MPF

K192687 · Nexxt Spine, LLC · Orthopedic

Jan 2020

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K192687 is an FDA 510(k) clearance for the TrellOss?-L MPF, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on January 9, 2020, 105 days after receiving the submission on September 26, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K192687 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2019
Decision Date	January 09, 2020
Days to Decision	105 days
Submission Type	Traditional
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.