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Theken Coral Spinal System

by Theken Spine, LLC

510(k) K091266

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 NumberK091266 Date10 Jun 2009ClearedStatusActive

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  • Withdrawn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, 21 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 Theken Coral Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. It provides posterior pedicle screw, posterior non-pedicle screw, or anterolateral fixation. The system's components lock together in various configurations to promote spinal fusion.

The Theken Coral Spinal System is operated by surgeons in clinical or operating room settings and is intended for use in skeletally mature patients. It is supplied with the authorization of FDA 510(k) clearance, with the reference number K091266. The device is a product of Theken Spine, LLC, with the product code NKB.

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Questions

AI-generated answers, 21 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 Theken Coral Spinal System used for?

    The Theken Coral Spinal System is used as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system to promote spinal fusion in skeletally mature patients.

  • Is the Theken Coral Spinal System supplied sterile?

    The description does not specify if the device is supplied sterile, but it is intended for use in clinical or operating room settings.

  • What is the regulatory status of the Theken Coral Spinal System?

    The device has FDA 510(k) clearance with the reference number K091266, indicating it is substantially equivalent to a predicate device.