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Pilot Spinal System

by Life Spine 2 variants

510(k) K083865

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 NumberK083865 Date28 Jan 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  • Withdrawn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
MNI
Device class
Class II
Regulation
21 CFR Part 888.3070
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 Pilot Spinal System is a spinal system used for instrumenting the thoracic and lumbar spine. It is indicated for the treatment of degeneration, tumor, or trauma in these spinal regions.

The system can be used in both open and minimally invasive procedures. Screw heads can be pre-loaded with the spinal rod, placed onto MIS guides, and attached to the posted screw construct. It is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user. The device received FDA 510(k) clearance (K083865) and is classified under product code MNI.

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  • Arx 13-5545-13

    Class II

  • Arx 13-5540-13

    Class II

  • Arx 13-6545-13

    Class II

See all devices from Life Spine, Inc. →

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 Pilot Spinal System used for?

    The Pilot Spinal System is used for instrumenting the thoracic and lumbar spine to treat conditions such as degeneration, tumor, or trauma in these spinal regions, providing stabilization during surgical procedures.

  • How is the Pilot Spinal System supplied and is it reusable?

    The Pilot Spinal System is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user, allowing for multiple uses following proper reprocessing protocols.

  • What procedures can the Pilot Spinal System be used in?

    The Pilot Spinal System can be used in both open and minimally invasive procedures, with screw heads designed to be pre-loaded with the spinal rod and placed onto MIS guides for attachment to the posted screw construct.