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FDA 510(k)

Neocis Guidance System (NGS) with Patient Splints

K-Number: K200805 · 2020-07-28

ApplicantNeocis, Inc.
Decision Date2020-07-28
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) with Patient Splints is the device name listed in this FDA 510(k) record. The listed applicant is Neocis, Inc.. It received FDA 510(k) clearance on 2020-07-28 under 510(k) number K200805. 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 Neocis Guidance System (NGS) with Patient Splints?

Neocis Guidance System (NGS) with Patient Splints is a medical device that received FDA 510(k) clearance on 2020-07-28. The listed applicant is Neocis, Inc.. The 510(k) number is K200805.

When did Neocis Guidance System (NGS) with Patient Splints receive FDA 510(k) clearance?

Neocis Guidance System (NGS) with Patient Splints received FDA 510(k) clearance on 2020-07-28, under 510(k) number K200805.

Who is the listed applicant for Neocis Guidance System (NGS) with Patient Splints?

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

What is the FDA product code for Neocis Guidance System (NGS) with Patient Splints?

The FDA product code for Neocis Guidance System (NGS) with Patient Splints is PLV.

Other records listing Neocis, Inc. as applicant

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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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