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FDA 510(k)

QUANTUM® Patient Specific Instrumentation (PSI) System

K-Number: K211883 · 2021-08-11

ApplicantIn2bones Sas
Decision Date2021-08-11
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUANTUM® Patient Specific Instrumentation (PSI) System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K211883. 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® Patient Specific Instrumentation (PSI) System?

QUANTUM® Patient Specific Instrumentation (PSI) System is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is In2bones Sas. The 510(k) number is K211883.

When did QUANTUM® Patient Specific Instrumentation (PSI) System receive FDA 510(k) clearance?

QUANTUM® Patient Specific Instrumentation (PSI) System received FDA 510(k) clearance on 2021-08-11, under 510(k) number K211883.

Who is the listed applicant for QUANTUM® Patient Specific Instrumentation (PSI) System?

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® Patient Specific Instrumentation (PSI) System?

The FDA product code for QUANTUM® Patient Specific Instrumentation (PSI) System 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.

K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemK230313QUANTUM Patient Specific Instrumentation (PSI) SystemK191380Quantum® Total Ankle ProsthesisK173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemK173616DIP Arthrodesis SystemK173121Ankle Fusion Plating System

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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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