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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 the device name listed in this FDA 510(k) record. The listed applicant is Orbbo Surgical, LLC. It received FDA 510(k) clearance on 2017-02-16 under 510(k) 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. The listed applicant is Orbbo Surgical, LLC. The 510(k) number is K163602.

When did Kepler I Cervical Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for Kepler I Cervical Plate System?

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 Kepler I Cervical Plate System?

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

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 IIK163566Hubble I SystemK163180Hubble II

Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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