MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides— 510(k) K200792

Name: FDA 510(k) clearance K200792
Creator: U.S. Food and Drug Administration
Published: 2020-10-05

Substantially Equivalent

Medacta Inernational SA

FDA 510(k) clearance K200792 for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, Substantially Equivalent on 2020-10-05. Applicant: Medacta Inernational SA. Device class: 2.

Clearance details

Applicant: Medacta Inernational SA
Product code: Code PQC
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2020-03-26
Decision date: 2020-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code PQC

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K253472 — FIREFLY® Pedicle Screw Navigation Guide2026-02-25
K231483 — MySpine Unilateral Guides2023-07-21
K203673 — MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)2021-04-06
K181883 — FIREFLY® Midline Navigation Guide2018-10-03
K181399 — FIREFLY® Pedicle Screw Navigation Guide2018-07-24

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Data sourced from openFDA. This site is unofficial and independent of the FDA.