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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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