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FDA 510(k)

Kepler I Cervical Plate System

K-Number: K163602 · 2017-02-16

ApplicantOrbbo Surgical, LLC
Decision Date2017-02-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kepler I Cervical Plate System is a medical device manufactured by Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2017-02-16 under approval number K163602. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kepler I Cervical Plate System?

Kepler I Cervical Plate System is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Orbbo Surgical, LLC. The 510(k) number is K163602.

When was Kepler I Cervical Plate System approved by the FDA?

Kepler I Cervical Plate System received FDA 510(k) clearance on 2017-02-16, under approval number K163602.

What company makes Kepler I Cervical Plate System?

Kepler I Cervical Plate System is manufactured by Orbbo Surgical, LLC.

What is the FDA product code for Kepler I Cervical Plate System?

The FDA product code for Kepler I Cervical Plate System is KWQ.

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Other Devices by Orbbo Surgical, LLC

K163180Hubble II K163265Kepler II K163566Hubble I System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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.

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