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FDA 510(k)

RTS Lesser MTP Implant System

K-Number: K173491 · 2018-02-23

ApplicantIn2bones USA, LLC
Decision Date2018-02-23
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RTS Lesser MTP Implant System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173491. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RTS Lesser MTP Implant System?

RTS Lesser MTP Implant System is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is In2bones USA, LLC. The 510(k) number is K173491.

When did RTS Lesser MTP Implant System receive FDA 510(k) clearance?

RTS Lesser MTP Implant System received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173491.

Who is the listed applicant for RTS Lesser MTP Implant System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RTS Lesser MTP Implant System?

The FDA product code for RTS Lesser MTP Implant System is KWH.

Other records listing In2bones USA, LLC 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.

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Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLC

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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