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FDA 510(k)

RTS Flexible 1 MPJ Implant w/Grommets

K-Number: K153609 · 2016-09-08

ApplicantIn2bones USA, LLC
Decision Date2016-09-08
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RTS Flexible 1 MPJ Implant w/Grommets 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 2016-09-08 under 510(k) number K153609. 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 Flexible 1 MPJ Implant w/Grommets?

RTS Flexible 1 MPJ Implant w/Grommets is a medical device that received FDA 510(k) clearance on 2016-09-08. The listed applicant is In2bones USA, LLC. The 510(k) number is K153609.

When did RTS Flexible 1 MPJ Implant w/Grommets receive FDA 510(k) clearance?

RTS Flexible 1 MPJ Implant w/Grommets received FDA 510(k) clearance on 2016-09-08, under 510(k) number K153609.

Who is the listed applicant for RTS Flexible 1 MPJ Implant w/Grommets?

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 Flexible 1 MPJ Implant w/Grommets?

The FDA product code for RTS Flexible 1 MPJ Implant w/Grommets is KWH.

Other records listing In2bones USA, LLC as applicant

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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, LLCK173491RTS Lesser MTP Implant SystemIn2bones 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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