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FDA 510(k)

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

K-Number: K220888 · 2022-05-24

ApplicantMedacta International S.A.
Decision Date2022-05-24
Product CodeQSR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-05-24 under approval number K220888. The device is classified under product code QSR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides?

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides is a medical device that received FDA 510(k) clearance on 2022-05-24. It is manufactured by Medacta International S.A.. The 510(k) number is K220888.

When was MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides approved by the FDA?

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides received FDA 510(k) clearance on 2022-05-24, under approval number K220888.

What company makes MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides?

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides is manufactured by Medacta International S.A..

What is the FDA product code for MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides?

The FDA product code for MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides is QSR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

View all 146 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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