Skip to content

Spinal Sphere System

by Life Spine

510(k) K073274

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK073274 Date17 Mar 2008ClearedStatusActive

Official records

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  • Withdrawn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
NVR
Device class
Class III
Advisory committee
Unknown
FDA decision
SESU

Overview

AI-generated summary, 18 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 Spinal Sphere System is an Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar, designed to provide stabilization and promote intervertebral body fusion. It is inserted between vertebral bodies from L3 to S1 to maintain alignment and facilitate bone healing during spinal fusion procedures.

This device is intended for single-use in surgical settings and is classified as a Class III medical device under FDA regulations. Supplied sterile, it requires proper handling and storage as per manufacturer guidelines. Authorized under FDA 510(k) clearance (K073274), it adheres to spinal orthopedic standards for lumbar applications.

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

See all devices from Life Spine, Inc. →