Cleared Traditional

Shoreline Threaded TruProfile? Plate

K211903 · SeaSpine Orthopedics Corporation · Orthopedic
Aug 2021
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K211903 is an FDA 510(k) clearance for the Shoreline Threaded TruProfile? Plate, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on August 30, 2021, 70 days after receiving the submission on June 21, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K211903 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2021
Decision Date August 30, 2021
Days to Decision 70 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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