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FDA 510(k)

Neocis Guidance System (NGS) with Chairside Splint

K-Number: K173402 · 2018-02-22

ApplicantNeocis, Inc.
Decision Date2018-02-22
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) with Chairside Splint is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2018-02-22 under approval number K173402. 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 Chairside Splint?

Neocis Guidance System (NGS) with Chairside Splint is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Neocis, Inc.. The 510(k) number is K173402.

When was Neocis Guidance System (NGS) with Chairside Splint approved by the FDA?

Neocis Guidance System (NGS) with Chairside Splint received FDA 510(k) clearance on 2018-02-22, under approval number K173402.

What company makes Neocis Guidance System (NGS) with Chairside Splint?

Neocis Guidance System (NGS) with Chairside Splint is manufactured by Neocis, Inc..

What is the FDA product code for Neocis Guidance System (NGS) with Chairside Splint?

The FDA product code for Neocis Guidance System (NGS) with Chairside Splint is PLV.

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Related PubMed Literature

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Other Devices by Neocis, Inc.

K161399Neocis Guidance System K182776Neocis Guidance System K191363Neocis Planning Software Application (NPSA) for 3rd Party PCs K191605Neocis Guidance System (NGS) K203401Neocis Guidance System (NGS) with Patient Splints (EPS) K202264Neocis Guidance System (NGS) with Yomi Plan v2.0

View all 18 devices →

Related Devices (Code: PLV)

K161399Neocis Guidance SystemNeocis, Inc. K161406NavidentClaronav, Inc. K182776Neocis Guidance SystemNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)Neocis, Inc. K203401Neocis Guidance System (NGS) with Patient Splints (EPS)Neocis, 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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