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Comet Anterior Cervical Plate System

by Apollo Spine, Inc.

510(k) K090751

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 · Special NumberK090751 Date23 Oct 2009ClearedStatusActive

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  • Withdrawn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, 28 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 Comet Anterior Cervical Plate System is a spinal fixation device consisting of metal plates and fixation screws. It is indicated for anterior cervical fixation at levels C2-C7 for degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), and spinal stenosis.

The system includes multi-level plate lengths (dual-level 24-48mm; triple-level 36-72mm) and a 3.3mm diameter screw option. It is supplied non-sterile and intended for single-use. The device received FDA 510(k) clearance (K090751) and is classified under product code KWQ with orthopedic advisory committee review.

Other devices from Apollo Spine, Inc.

Questions

AI-generated answers, 28 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 Comet Anterior Cervical Plate System used for?

    The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation at levels C2-C7 to treat degenerative disc disease, spondylolisthesis, trauma such as fracture or dislocation, and spinal stenosis. It stabilizes the spine following anterior discectomy or corpectomy procedures by securing plates and screws to the vertebral bodies.

  • How is the Comet Anterior Cervical Plate System supplied and is it reusable?

    The device is supplied non-sterile and intended for single-use only. It must be sterilized by the user prior to implantation and should not be reused, as reprocessing may compromise structural integrity and increase the risk of failure or infection.

  • What sizes and configurations are available in the Comet Anterior Cervical Plate System?

    The system includes multi-level anterior cervical plates with dual-level lengths ranging from 24mm to 48mm and triple-level lengths from 36mm to 72mm. It also offers a 3.3mm diameter fixation screw option, allowing surgeons to select appropriate constructs based on anatomy and fusion levels.