Cleared Traditional

Vertiwedge? Intraosseous System

K241468 · Foundation Surgical Group, Inc. · Orthopedic

Nov 2024

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K241468 is an FDA 510(k) clearance for the Vertiwedge? Intraosseous System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Foundation Surgical Group, Inc. (Scottsdale, US). The FDA issued a Cleared decision on November 7, 2024, 167 days after receiving the submission on May 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K241468 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2024
Decision Date	November 07, 2024
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF