Cleared Traditional

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

K251965 · Alphatec Spine, Inc. · Orthopedic
Aug 2025
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K251965 is an FDA 510(k) clearance for the Proximity Anterior Cervical Plate System; Segmental Plating System (SPS), 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 August 28, 2025, 63 days after receiving the submission on June 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K251965 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2025
Decision Date August 28, 2025
Days to Decision 63 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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