Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K171170.

When did M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETEDNCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT07693933Biodegradable Magnesium Screws for Unstable Ankle Fracture SurgeryNOT_YET_RECRUITINGNCT07790068Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)ACTIVE_NOT_RECRUITING

Other records listing Medacta International S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254202MectaLIF 3D Metal AnteriorK253940M.U.S.T. Pedicle Screw System - ExtensionK253328GMK 3D Metal Tibial Tray ExtensionK250644MSS - Monobloc stemK251043Mpact 3D Metal Implants Extension – DMLS TechnologyK252847NextAR Hip Platform

View all 146 devices →

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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.

↑