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SOLSTICE OCT System

by Life Spine, Inc. 3 variants

510(k) K143249

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 NumberK143249 Date7 Apr 2015ClearedStatusActive

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  • Withdrawn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
KWP
Device class
Class II
Regulation
21 CFR Part 888.3050
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 SOLSTICE OCT System is an orthopedic device designed for use in spinal procedures. It provides a comprehensive system for implantation and fixation in the spine.

The system is supplied as a sterile, single-use device and is not intended for MRI environments. It is authorized under FDA 510K clearance with product code KWP and model number K143249.

Other devices from Life Spine, Inc.

  • Arx 13-5550-13

    Class II

  • Arx 13-6540-13

    Class II

  • Arx 13-6550-13

    Class II

  • 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, 23 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 SOLSTICE OCT System used for?

    The SOLSTICE OCT System is an orthopedic device designed for use in spinal procedures, providing a comprehensive system for implantation and fixation in the spine.

  • Is the SOLSTICE OCT System reusable or single-use?

    The SOLSTICE OCT System is supplied as a sterile, single-use device and is not intended for MRI environments.

  • What is the regulatory status of the SOLSTICE OCT System?

    The SOLSTICE OCT System is authorized under FDA 510K clearance with product code KWP and model number K143249.

  • Who manufactures the SOLSTICE OCT System?

    The SOLSTICE OCT System is manufactured by Life Spine, Inc., located in Hoffman Estates, IL.