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FDA 510(k)

SENTIO MMG Pedicle Access Needles

K-Number: K173134 · 2018-03-22

ApplicantMedos International SARL
Decision Date2018-03-22
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SENTIO MMG Pedicle Access Needles is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2018-03-22 under 510(k) number K173134. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTIO MMG Pedicle Access Needles?

SENTIO MMG Pedicle Access Needles is a medical device that received FDA 510(k) clearance on 2018-03-22. The listed applicant is Medos International SARL. The 510(k) number is K173134.

When did SENTIO MMG Pedicle Access Needles receive FDA 510(k) clearance?

SENTIO MMG Pedicle Access Needles received FDA 510(k) clearance on 2018-03-22, under 510(k) number K173134.

Who is the listed applicant for SENTIO MMG Pedicle Access Needles?

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

What is the FDA product code for SENTIO MMG Pedicle Access Needles?

The FDA product code for SENTIO MMG Pedicle Access Needles is PDQ.

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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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