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

FDA 510(k)

Hubble I System

K-Number: K163566 · 2017-02-09

ApplicantOrbbo Surgical, LLC
Decision Date2017-02-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hubble I System is a medical device manufactured by Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2017-02-09 under approval number K163566. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hubble I System?

Hubble I System is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Orbbo Surgical, LLC. The 510(k) number is K163566.

When was Hubble I System approved by the FDA?

Hubble I System received FDA 510(k) clearance on 2017-02-09, under approval number K163566.

What company makes Hubble I System?

Hubble I System is manufactured by Orbbo Surgical, LLC.

What is the FDA product code for Hubble I System?

The FDA product code for Hubble I System is NKB.

Other Devices by Orbbo Surgical, LLC

K163180Hubble II K163265Kepler II K163602Kepler I Cervical Plate System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

↑