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FDA 510(k)

Practical Navigation Surgical Guidance System (PNSGS)

K-Number: K202184 · 2021-02-24

ApplicantPractical Navigation, LLC
Decision Date2021-02-24
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Practical Navigation Surgical Guidance System (PNSGS) is the device name listed in this FDA 510(k) record. The listed applicant is Practical Navigation, LLC. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K202184. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Practical Navigation Surgical Guidance System (PNSGS)?

Practical Navigation Surgical Guidance System (PNSGS) is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Practical Navigation, LLC. The 510(k) number is K202184.

When did Practical Navigation Surgical Guidance System (PNSGS) receive FDA 510(k) clearance?

Practical Navigation Surgical Guidance System (PNSGS) received FDA 510(k) clearance on 2021-02-24, under 510(k) number K202184.

Who is the listed applicant for Practical Navigation Surgical Guidance System (PNSGS)?

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

What is the FDA product code for Practical Navigation Surgical Guidance System (PNSGS)?

The FDA product code for Practical Navigation Surgical Guidance System (PNSGS) is OLO.

Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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