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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 the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2020-01-29 under 510(k) 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. The listed applicant is In2bones Sas. The 510(k) number is K191380.

When did Quantum® Total Ankle Prosthesis receive FDA 510(k) clearance?

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

Who is the listed applicant for Quantum® Total Ankle Prosthesis?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing In2bones Sas 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.

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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.

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