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FDA 510(k)

Quantum® Total Ankle Prosthesis

K-Number: K191380 · 2020-01-29

ApplicantIn2bones Sas
Decision Date2020-01-29
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Quantum® Total Ankle Prosthesis is a medical device manufactured by In2bones Sas. It received FDA 510(k) clearance on 2020-01-29 under approval number K191380. 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 Quantum® Total Ankle Prosthesis?

Quantum® Total Ankle Prosthesis is a medical device that received FDA 510(k) clearance on 2020-01-29. It is manufactured by In2bones Sas. The 510(k) number is K191380.

When was Quantum® Total Ankle Prosthesis approved by the FDA?

Quantum® Total Ankle Prosthesis received FDA 510(k) clearance on 2020-01-29, under approval number K191380.

What company makes Quantum® Total Ankle Prosthesis?

Quantum® Total Ankle Prosthesis is manufactured by In2bones Sas.

What is the FDA product code for Quantum® Total Ankle Prosthesis?

The FDA product code for Quantum® Total Ankle Prosthesis is HSN.

Related Clinical Trials

NCT06539936 Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses RECRUITING NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT01754363 Survivorship of Attune Primary Total Knee Prosthesis ACTIVE_NOT_RECRUITING NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING NCT07569549 Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy NOT_YET_RECRUITING

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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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