Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APTUS Foot System 2.8-3.5

K-Number: K232105 · 2024-04-19

ApplicantMedartis AG
Decision Date2024-04-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS Foot System 2.8-3.5 is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2024-04-19 under approval number K232105. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTUS Foot System 2.8-3.5?

APTUS Foot System 2.8-3.5 is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Medartis AG. The 510(k) number is K232105.

When was APTUS Foot System 2.8-3.5 approved by the FDA?

APTUS Foot System 2.8-3.5 received FDA 510(k) clearance on 2024-04-19, under approval number K232105.

What company makes APTUS Foot System 2.8-3.5?

APTUS Foot System 2.8-3.5 is manufactured by Medartis AG.

What is the FDA product code for APTUS Foot System 2.8-3.5?

The FDA product code for APTUS Foot System 2.8-3.5 is HRS.

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: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑