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Title 2 Polyaxial Spinal System

by Zimmer Spine, Inc.

510(k) K133086

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 NumberK133086 Date27 Nov 2013ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Title 2 Polyaxial Spinal System is a pedicle screw system designed to provide immobilization and stabilization of spinal segments. It is indicated as an adjunct to fusion for the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis and degenerative disc disease.

This system is intended for use in skeletally mature patients and supports single or multi-level fixation. The instrumentation facilitates compression, distraction, and reduction, and is compatible with both open and minimally invasive surgical approaches. This device has received FDA 510(k) clearance.

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Questions

AI-generated answers, 6 Oct 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 intended use of the Title 2 Polyaxial Spinal System?

    The Title 2 Polyaxial Spinal System is a pedicle screw system designed to provide immobilization and stabilization of spinal segments. It is indicated as an adjunct to fusion for treating acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, such as degenerative disc disease and degenerative spondylolisthesis.

  • Is this spinal system suitable for multi-level fixation?

    This system is intended for use in skeletally mature patients and supports both single and multi-level fixation procedures.

  • Can this system be used in minimally invasive surgeries?

    The instrumentation is designed to be compatible with both open and minimally invasive surgical approaches, allowing for flexibility in surgical technique while facilitating compression, distraction, and reduction.

  • What is the regulatory status of this device?

    The Title 2 Polyaxial Spinal System has received FDA 510(k) clearance under K133086, confirming it is substantially equivalent to existing devices for its intended use.