Cleared Traditional

VerteLoc Spinal System

K231134 · Signature Orthopaedics Pty, Ltd. · Orthopedic
Feb 2024
Decision
298d
Days
Class 2
Risk

About This 510(k) Submission

K231134 is an FDA 510(k) clearance for the VerteLoc Spinal System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Signature Orthopaedics Pty, Ltd. (Lane Cove West, AU). The FDA issued a Cleared decision on February 13, 2024, 298 days after receiving the submission on April 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K231134 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2023
Decision Date February 13, 2024
Days to Decision 298 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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