FDA 510(k)

Hubble II

K-Number: K163180 · 2016-12-29

Decision Date2016-12-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hubble II is a medical device manufactured by Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2016-12-29 under approval number K163180. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hubble II?

Hubble II is a medical device that received FDA 510(k) clearance on 2016-12-29. It is manufactured by Orbbo Surgical, LLC. The 510(k) number is K163180.

When was Hubble II approved by the FDA?

Hubble II received FDA 510(k) clearance on 2016-12-29, under approval number K163180.

What company makes Hubble II?

Hubble II is manufactured by Orbbo Surgical, LLC.

What is the FDA product code for Hubble II?

The FDA product code for Hubble II is MAX.

Other Devices by Orbbo Surgical, LLC

K163265Kepler II K163602Kepler I Cervical Plate System K163566Hubble I System

Related Devices (Code: MAX)

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc. K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.