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Theken Atoll Cervico-Thoracic System

by Theken Spine, LLC 2 variants

510(k) K070638

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 NumberK070638 Date30 May 2007ClearedStatusActive

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  • Withdrawn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, 22 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 Atoll Cervico-Thoracic System is a posterior spinal fixation system comprised of titanium alloy screws, hooks, rods, and connectors. It is used by surgeons to stabilize the cervico-thoracic spine from C1 to T3 to promote fusion.

Components are available in various sizes to accommodate patient anatomy, with screws specifically indicated for thoracic placement from T1 to T3. This device has received FDA 510(k) clearance.

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