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FDA 510(k)

PILLAR PALATAL IMPLANT SYSTEM

K-Number: K110623 · 2012-02-10

ApplicantMedtronic Xomed, Inc.
Decision Date2012-02-10
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PILLAR PALATAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2012-02-10 under 510(k) number K110623. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PILLAR PALATAL IMPLANT SYSTEM?

PILLAR PALATAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K110623.

When did PILLAR PALATAL IMPLANT SYSTEM receive FDA 510(k) clearance?

PILLAR PALATAL IMPLANT SYSTEM received FDA 510(k) clearance on 2012-02-10, under 510(k) number K110623.

Who is the listed applicant for PILLAR PALATAL IMPLANT SYSTEM?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PILLAR PALATAL IMPLANT SYSTEM?

The FDA product code for PILLAR PALATAL IMPLANT SYSTEM is LRK.

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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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