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

FDA 510(k)

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

K-Number: K130533 · 2013-05-17

ApplicantTornier S.A.S.
Decision Date2013-05-17
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K130533. 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 SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS?

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Tornier S.A.S.. The 510(k) number is K130533.

When did SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS receive FDA 510(k) clearance?

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS received FDA 510(k) clearance on 2013-05-17, under 510(k) number K130533.

Who is the listed applicant for SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS?

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

What is the FDA product code for SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS?

The FDA product code for SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS is HSN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tornier S.A.S. as applicant

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.

K232265BLUEPRINT™ Patient Specific InstrumentationK222510Blueprint Mixed Reality systemK203315BLUEPRINT™ Patient Specific InstrumentationK190521Aequalis Ascend Flex Shoulder SystemK162800BLUEPRINT Patient Specific InstrumentationK161789BLUEPRINT Patient Specific Instrumentation

View all 14 devices →

Related Devices (Code: HSN)

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.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

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.

↑