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FDA 510(k)

M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws

K-Number: K171170 · 2017-05-25

ApplicantMedacta International S.A.
Decision Date2017-05-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-05-25 under approval number K171170. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws?

M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws is a medical device that received FDA 510(k) clearance on 2017-05-25. It is manufactured by Medacta International S.A.. The 510(k) number is K171170.

When was M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws approved by the FDA?

M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws received FDA 510(k) clearance on 2017-05-25, under approval number K171170.

What company makes M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws?

M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws is manufactured by Medacta International S.A..

What is the FDA product code for M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws?

The FDA product code for M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws is NKB.

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

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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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