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Data / Medical devices / Posterior Cervical Screw Placement Guide

Posterior Cervical Screw Placement Guide (QSD): 3 FDA-registered makers in 2 countries

3 establishments in 2 countries are registered with the FDA to make Posterior Cervical Screw Placement Guide (product code QSD, Class 2, 21 CFR 888.3075). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on December 7, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QSD
Device class
2
Regulation
888.3075
Medical specialty
Orthopedic

Makers by country

CountryMakers
Switzerland2
United States1

Makers of Posterior Cervical Screw Placement Guide

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer1December 7, 2023000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer1December 7, 2023000api.fda.gov
Mighty Oak MedicalEnglewood, CO, United StatesComplaint file establishment, Manufacturer1October 26, 2022000api.fda.gov

Updated December 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.