FDA.report

510(k) K231483

Device
MySpine Unilateral Guides
Applicant
Medacta International S.A.
510(k) number
K231483
Product code
PQC
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-05-23
Regulation
888.3070
Classification name
Pedicle Screw Placement Guide
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro CH 6874 6874

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
07630345787163MySpine Unilateral GuideMedacta International SA2023-07-25
07630345786203MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787026MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787033MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787040MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787057MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787064MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787071MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787088MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787095MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787101MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787118MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787125MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787132MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787149MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787156MySpine Unilateral GuideMedacta International SA2023-07-25
07630345799005MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787170MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787187MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787194MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787200MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787217MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787224MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787231MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787248MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787255MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787262MySpine Unilateral GuideMedacta International SA2023-07-25
07630345787279MySpine Unilateral GuideMedacta International SA2023-07-25
07630345798978MySpine Unilateral GuideMedacta International SA2023-07-25
07630345798985MySpine Unilateral GuideMedacta International SA2023-07-25

Other 510(k) Records For Product Code PQC

510(k)DeviceApplicantDecision date
K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical2026-02-25
K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A.2021-04-06
K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA2020-10-05
K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.2018-10-03
K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.2018-07-24
K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.2018-04-19
K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.2016-10-28