Skip to content

Spinal Elements Posterior Cervical/Thoracic Spinal System

by Spinal Elements, Inc.

510(k) K120467

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120467 Date30 Jul 2012ClearedStatusActive

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  • Withdrawn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
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 25 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 Elements Posterior Cervical/Thoracic Spinal System is a medical device intended for posterior fixation of the cervical and thoracic spine (CI-T3). It is designed to address conditions such as degenerative disc disease, spondylolisthesis, spinal stenosis, and trauma.

The device is supplied as a spinal implant system, including polyaxial screws and rods. It is intended for use in spinal fusion surgery and is regulated under FDA 510(k) clearance. Proper storage and handling should follow the manufacturer's guidelines.

Other devices from Spinal Elements, Inc.

See all devices from Spinal Elements, Inc. →