Cleared Traditional

CAPRI Corpectomy Cage System

K211320 · K2m, Inc. · Orthopedic

Feb 2022

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K211320 is an FDA 510(k) clearance for the CAPRI Corpectomy Cage System, a Spinal Vertebral Body Replacement Device - Cervical (Class II — Special Controls, product code PLR), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on February 24, 2022, 300 days after receiving the submission on April 30, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K211320 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2021
Decision Date	February 24, 2022
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLR — Spinal Vertebral Body Replacement Device - Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3060
Definition	Vertebral Body Replacement In The Cervical Spine.