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FDA 510(k)

INLIANT Surgical Navigation System

K-Number: K213392 · 2022-02-22

ApplicantNavigate Surgical Technologies, Inc.
Decision Date2022-02-22
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INLIANT Surgical Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Navigate Surgical Technologies, Inc.. It received FDA 510(k) clearance on 2022-02-22 under 510(k) number K213392. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INLIANT Surgical Navigation System?

INLIANT Surgical Navigation System is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Navigate Surgical Technologies, Inc.. The 510(k) number is K213392.

When did INLIANT Surgical Navigation System receive FDA 510(k) clearance?

INLIANT Surgical Navigation System received FDA 510(k) clearance on 2022-02-22, under 510(k) number K213392.

Who is the listed applicant for INLIANT Surgical Navigation System?

The FDA 510(k) record lists Navigate Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INLIANT Surgical Navigation System?

The FDA product code for INLIANT Surgical Navigation System is PLV.

Related Devices (Code: PLV)

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.

K252376Yomi S Robotic SystemNeocis, Inc.K251835Yomi Robotic SystemNeocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi Robotic SystemNeocis, Inc.K210947NavidentClaronav, Inc.K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.

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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