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FDA 510(k)

LigaPASS

K-Number: K172021 · 2017-08-30

ApplicantMedicrea International SA
Decision Date2017-08-30
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LigaPASS is a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2017-08-30 under approval number K172021. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LigaPASS?

LigaPASS is a medical device that received FDA 510(k) clearance on 2017-08-30. It is manufactured by Medicrea International SA. The 510(k) number is K172021.

When was LigaPASS approved by the FDA?

LigaPASS received FDA 510(k) clearance on 2017-08-30, under approval number K172021.

What company makes LigaPASS?

LigaPASS is manufactured by Medicrea International SA.

What is the FDA product code for LigaPASS?

The FDA product code for LigaPASS is OWI.

Other Devices by Medicrea International SA

K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System K160640PASS XS Spinal System K160698LigaPASS K161627PASS LP Spinal System K161149PASS OCT Spinal System K160756PASS OCT Spinal System

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Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, 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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