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)

Naviswiss Hip Navigation System

K-Number: K193094 · 2020-06-10

ApplicantNaviswiss AG
Decision Date2020-06-10
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Naviswiss Hip Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Naviswiss AG. It received FDA 510(k) clearance on 2020-06-10 under 510(k) number K193094. 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 Naviswiss Hip Navigation System?

Naviswiss Hip Navigation System is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Naviswiss AG. The 510(k) number is K193094.

When did Naviswiss Hip Navigation System receive FDA 510(k) clearance?

Naviswiss Hip Navigation System received FDA 510(k) clearance on 2020-06-10, under 510(k) number K193094.

Who is the listed applicant for Naviswiss Hip Navigation System?

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

What is the FDA product code for Naviswiss Hip Navigation System?

The FDA product code for Naviswiss Hip Navigation System is OLO.

Other records listing Naviswiss AG 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.

K223351Naviswiss KneeK211429NAVIPLAN - CT Planning Software for Total Hip Replacement

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.

↑