Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zavation Navigation Instrument System

K-Number: K223808 · 2023-07-12

ApplicantZavation Medical Products, LLC
Decision Date2023-07-12
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zavation Navigation Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K223808. 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 Zavation Navigation Instrument System?

Zavation Navigation Instrument System is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K223808.

When did Zavation Navigation Instrument System receive FDA 510(k) clearance?

Zavation Navigation Instrument System received FDA 510(k) clearance on 2023-07-12, under 510(k) number K223808.

Who is the listed applicant for Zavation Navigation Instrument System?

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

What is the FDA product code for Zavation Navigation Instrument System?

The FDA product code for Zavation Navigation Instrument System is OLO.

Other records listing Zavation Medical Products, LLC as applicant

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.

K253943Tiger 2 SystemK243908Tiger 2 SystemK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemK231811Zavation Connector SystemK230731Zavation ALIF SystemK221726Uni-FuZe-C Bone Strip

View all 31 devices →

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.

↑