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Phantom Plus Cage System

by Us Spine

510(k) K082801

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 NumberK082801 Date22 Dec 2008ClearedStatusActive

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  • Withdrawn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
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Phantom Plus Cage System is an interbody spinal fusion device designed for lumbar and cervical spine applications. It is classified as an orthopedic spinal fusion cage, intended to provide structural support and facilitate bone growth between vertebrae. The device is constructed to be implanted within the spinal disc space to restore disc height and promote spinal stability.

The system is supplied sterile and intended for single-use. It is used in surgical settings for spinal fusion procedures, requiring placement with supplemental spinal fixation systems such as pedicle screws. The cages are filled with autogenous bone graft material to enhance fusion outcomes. Regulatory clearance under FDA 510(k) (K082801) confirms its compliance with orthopedic device standards for spinal applications.

Other devices from Us Spine

Questions

AI-generated answers, 1 Oct 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 Phantom Plus Cage System used for?

    The Phantom Plus Cage System is designed for interbody spinal fusion procedures in the lumbar and cervical spine. It is implanted within the spinal disc space to restore disc height, maintain proper spinal alignment, and facilitate bone growth between vertebrae, thereby enhancing spinal stability.

  • How is the Phantom Plus Cage System supplied and intended for use?

    The system is supplied sterile and is intended for single-use only. It is meant to be used in surgical settings, where it is placed within the spinal disc space alongside supplemental spinal fixation systems, such as pedicle screws. The cages are then filled with autogenous bone graft material to promote successful fusion outcomes.

  • Does the Phantom Plus Cage System require any additional components for proper function?

    Yes, the Phantom Plus Cage System is intended to be used in conjunction with supplemental spinal fixation systems, such as pedicle screws. These additional components help secure the cage in place and provide overall stability during the fusion process.

  • What type of bone graft material is recommended for use with this system?

    The Phantom Plus Cage System is designed to be filled with autogenous bone graft material, which is bone harvested from the patient’s own body. This type of graft is commonly used to enhance fusion outcomes by providing living cells that promote bone growth and integration within the cage.

  • Is the Phantom Plus Cage System approved for specific spinal regions?

    The Phantom Plus Cage System is approved for use in both lumbar and cervical spine applications. Its design allows for placement in these regions to address degenerative disc disease, spinal instability, or other conditions requiring interbody fusion.