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FDA 510(k)

Hubble II

K-Number: K163180 · 2016-12-29

ApplicantOrbbo Surgical, LLC
Decision Date2016-12-29
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hubble II is the device name listed in this FDA 510(k) record. The listed applicant is Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2016-12-29 under 510(k) 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. The listed applicant is Orbbo Surgical, LLC. The 510(k) number is K163180.

When did Hubble II receive FDA 510(k) clearance?

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

Who is the listed applicant for Hubble II?

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

What is the FDA product code for Hubble II?

The FDA product code for Hubble II is MAX.

Other records listing Orbbo Surgical, 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.

K163265Kepler IIK163602Kepler I Cervical Plate SystemK163566Hubble I System

Related Devices (Code: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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.

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