RTS Flexible 1 MPJ Implant w/Grommets— 510(k) K153609

Name: FDA 510(k) clearance K153609
Creator: U.S. Food and Drug Administration
Published: 2016-09-08

Substantially Equivalent

In2bones USA, LLC

FDA 510(k) clearance K153609 for RTS Flexible 1 MPJ Implant w/Grommets, Substantially Equivalent on 2016-09-08. Applicant: In2bones USA, LLC. Device class: 2.

Clearance details

Applicant: In2bones USA, LLC
Product code: Code KWH
Device class: Class 2
Regulation: 21 CFR 888.3720
Advisory panel: Orthopedic
Date received: 2015-12-17
Decision date: 2016-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.