Cleared Traditional

Karma? Fixation System

K190289 · Spinal Elements, Inc. · Orthopedic

Apr 2019

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K190289 is an FDA 510(k) clearance for the Karma? Fixation System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 3, 2019, 51 days after receiving the submission on February 11, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K190289 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	April 03, 2019
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3010
Definition	Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.