FDA 510(k)

APTUS Foot System

K-Number: K191636 · 2019-08-16

Decision Date2019-08-16

Product CodeJDR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

APTUS Foot System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2019-08-16 under approval number K191636. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS Foot System?

APTUS Foot System is a medical device that received FDA 510(k) clearance on 2019-08-16. It is manufactured by Medartis AG. The 510(k) number is K191636.

When was APTUS Foot System approved by the FDA?

APTUS Foot System received FDA 510(k) clearance on 2019-08-16, under approval number K191636.

What company makes APTUS Foot System?

APTUS Foot System is manufactured by Medartis AG.

What is the FDA product code for APTUS Foot System?

The FDA product code for APTUS Foot System is JDR.

Other Devices by Medartis AG

K172170APTUS(R) Wrist 2.5 System K161861APTUS® Coronoid 2.0 K181009APTUS CMC-I Fusion Plate System K181425APTUS® Proximal Humerus System K192297APTUS Wrist Arthrodesis Plates K191848APTUS Wrist Spanning Plates 2.5

View all 22 devices →

Related Devices (Code: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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.