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VersaLift Expandable System

by Life Spine, Inc.

510(k) K260837

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 NumberK260837 Date12 May 2026ClearedStatusActive

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 VersaLift Expandable System is an expandable interbody system used for spinal treatment. It is designed for micro invasive procedures, specifically for TLIF and PLIF procedures, and features a low 6mm starting height for insertion in constrained anatomy. The system employs controlled in-situ expansion, minimizing tissue disruption.

The VersaLift Expandable System is supplied by Life Spine, Inc. and has received FDA 510(k) clearance. It is intended for use in orthopedic applications, and its product code is MAX. The system is designed for use in surgical treatment of spinal disorders, with a focus on minimizing tissue disruption and facilitating insertion in constrained anatomy.

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  • Arx 13-5545-13

    Class II

  • Arx 13-5540-13

    Class II

  • Arx 13-6545-13

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See all devices from Life Spine, Inc. →

Questions

AI-generated answers, 6 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 VersaLift Expandable System used for?

    The VersaLift Expandable System is used for spinal treatment, specifically for TLIF and PLIF procedures, to minimize tissue disruption and facilitate insertion in constrained anatomy.

  • How is the VersaLift Expandable System supplied?

    The VersaLift Expandable System is supplied by Life Spine, Inc.

  • What is the starting height of the VersaLift Expandable System?

    The VersaLift Expandable System has a low 6mm starting height for insertion in constrained anatomy.