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Coral Spinal System

by Theken Spine, LLC

510(k) K120047

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 NumberK120047 Date3 Feb 2012ClearedStatusActive

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  • Withdrawn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
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Coral Spinal System is a posterior spinal fixation device classified as a non-cervical spinal fixation system. It is designed to provide structural support through pedicle screw fixation, non-pedicle screw fixation, or anterolateral fixation, facilitating spinal fusion in skeletally mature patients.

This system is intended for use in clinical or operating room settings by surgeons. It consists of modular components that lock together in various configurations, supplied as a reusable device with FDA 510(k) clearance under K120047. No specific sterility or MRI safety information is provided in the available data.

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