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 a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2016-09-08 under approval 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. It is manufactured by In2bones USA, LLC. The 510(k) number is K153609.
When was RTS Flexible 1 MPJ Implant w/Grommets approved by the FDA?
RTS Flexible 1 MPJ Implant w/Grommets received FDA 510(k) clearance on 2016-09-08, under approval number K153609.
What company makes RTS Flexible 1 MPJ Implant w/Grommets?
RTS Flexible 1 MPJ Implant w/Grommets is manufactured by In2bones USA, LLC.
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 Devices by In2bones USA, LLC
Related Devices (Code: KWH)
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.