Cleared Traditional

Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System

K233640 · Alphatec Spine, Inc. · Orthopedic

Feb 2024

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K233640 is an FDA 510(k) clearance for the Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 22, 2024, 101 days after receiving the submission on November 13, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K233640 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2023
Decision Date	February 22, 2024
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF