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FDA 510(k)

Neocis Guidance System (NGS) with Patient Splints (EPS)

K-Number: K203401 · 2020-12-15

ApplicantNeocis, Inc.
Decision Date2020-12-15
Product CodePLV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neocis Guidance System (NGS) with Patient Splints (EPS) is a medical device manufactured by Neocis, Inc.. It received FDA 510(k) clearance on 2020-12-15 under approval number K203401. 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 (EPS)?

Neocis Guidance System (NGS) with Patient Splints (EPS) is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Neocis, Inc.. The 510(k) number is K203401.

When was Neocis Guidance System (NGS) with Patient Splints (EPS) approved by the FDA?

Neocis Guidance System (NGS) with Patient Splints (EPS) received FDA 510(k) clearance on 2020-12-15, under approval number K203401.

What company makes Neocis Guidance System (NGS) with Patient Splints (EPS)?

Neocis Guidance System (NGS) with Patient Splints (EPS) is manufactured by Neocis, Inc..

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

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

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Neocis, Inc.

K161399Neocis Guidance System K182776Neocis Guidance System K173402Neocis Guidance System (NGS) with Chairside Splint K191363Neocis Planning Software Application (NPSA) for 3rd Party PCs K191605Neocis Guidance System (NGS) 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. K173402Neocis Guidance System (NGS) with Chairside SplintNeocis, Inc. K191363Neocis Planning Software Application (NPSA) for 3rd Party PCsNeocis, Inc. K191605Neocis Guidance System (NGS)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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