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FDA 510(k)

APTUS Foot System

K-Number: K191636 · 2019-08-16

ApplicantMedartis AG
Decision Date2019-08-16
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Foot System is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2019-08-16 under 510(k) 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. The listed applicant is Medartis AG. The 510(k) number is K191636.

When did APTUS Foot System receive FDA 510(k) clearance?

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

Who is the listed applicant for APTUS Foot System?

The FDA 510(k) record lists Medartis AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APTUS Foot System?

The FDA product code for APTUS Foot System is JDR.

Other records listing Medartis AG as applicant

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Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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