FDA 510(k) Applications for Medical Device Product Code "PQC"

FDA 510(k) Number Applicant Device Name Decision Date
K200792 Medacta Inernational SA MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides 10/05/2020
K231483 Medacta International S.A. MySpine Unilateral Guides 07/21/2023
K203673 Medacta International SA MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) 04/06/2021
K173472 Medacta International SA MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments 04/19/2018
K181883 Mighty Oak Medical Inc. FIREFLY« Midline Navigation Guide 10/03/2018
K162419 MIGHTY OAK MEDICAL INC. FIREFLY« Pedicle Screw Navigation Guide 10/28/2016
K181399 Mighty Oak Medical Inc. FIREFLY« Pedicle Screw Navigation Guide 07/24/2018


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