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FDA 510(k)

Integra Salto Total Ankle System

K-Number: K182878 · 2018-12-18

ApplicantAscension Orthopedics
Decision Date2018-12-18
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integra Salto Total Ankle System is a medical device manufactured by Ascension Orthopedics. It received FDA 510(k) clearance on 2018-12-18 under approval number K182878. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integra Salto Total Ankle System?

Integra Salto Total Ankle System is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Ascension Orthopedics. The 510(k) number is K182878.

When was Integra Salto Total Ankle System approved by the FDA?

Integra Salto Total Ankle System received FDA 510(k) clearance on 2018-12-18, under approval number K182878.

What company makes Integra Salto Total Ankle System?

Integra Salto Total Ankle System is manufactured by Ascension Orthopedics.

What is the FDA product code for Integra Salto Total Ankle System?

The FDA product code for Integra Salto Total Ankle System is HSN.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Ascension Orthopedics

K160830Integra External Fixation System K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System

Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

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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