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Kepler I Cervical Plate System

by Orbbo Surgical, LLC

510(k) K163602

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163602 Date16 Feb 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kepler I Cervical Plate System is a medical device indicated for temporary stabilization device for the anterior spine. It is used during the development of cervical spinal fusions in patients with degenerative disc disease, spinal stenosis, or spondylolisthesis.

The device is supplied by Orbbo Surgical, LLC and received FDA 510(k) clearance under K163602 on February 16, 2017. It is a substantially equivalent device classified under product code KWQ and reviewed by the Orthopedic advisory committee.

Other devices from Orbbo Surgical, LLC

  • Kepler II

    Class II

  • Hubble II

    Class II

  • Hubble I System

    Class II

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kepler I Cervical Plate System used for?

    The Kepler I Cervical Plate System is indicated for temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease, spinal stenosis, or spondylolisthesis.

  • Who manufactures the Kepler I Cervical Plate System and when was it cleared?

    The Kepler I Cervical Plate System is manufactured by Orbbo Surgical, LLC and received FDA 510(k) clearance under K163602 on February 16, 2017.

  • What regulatory pathway and product code apply to the Kepler I Cervical Plate System?

    The Kepler I Cervical Plate System was cleared via the traditional 510(k) pathway as a substantially equivalent device under product code KWQ and was reviewed by the Orthopedic advisory committee.