Cleared Traditional

Ascend VBR System, Ascend NanoTec VBR System

K232173 · Alphatec Spine, Inc. · Orthopedic
Oct 2023
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K232173 is an FDA 510(k) clearance for the Ascend VBR System, Ascend NanoTec VBR System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 6, 2023, 77 days after receiving the submission on July 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K232173 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2023
Decision Date October 06, 2023
Days to Decision 77 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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