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SETx Pedicle Screw System

by Xenco Medical LLC

510(k) K170611

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 NumberK170611 Date25 May 2017ClearedStatusActive

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  • Withdrawn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
FDA applicant
Xenco Medical, LLC
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 SETx Pedicle Screw System is an internal spinal fixation system comprised of longitudinal rods and polyaxial screws. It is a spinal fixation device that provides immobilization of spinal segments as an adjunct to fusion.

It is used in posterior, non-cervical pedicle fixation or anterolateral fixation. Operated by surgeons in clinical/OR settings, the system components facilitate stabilization of the spine in patients with degenerative disc disease, curvatures, spondylolisthesis, or trauma. The device is supplied as a single-use system and is authorized under FDA 510(k) clearance K170611.

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Questions

AI-generated answers, 1 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 SETx Pedicle Screw System used for?

    The SETx Pedicle Screw System is used as an internal spinal fixation device to provide immobilization of spinal segments as an adjunct to fusion. It is indicated for posterior, non-cervical pedicle fixation or anterolateral fixation in patients with degenerative disc disease, curvatures, spondylolisthesis, or trauma, and is operated by surgeons in clinical or OR settings.

  • How is the SETx Pedicle Screw System supplied and is it reusable?

    The SETx Pedicle Screw System is supplied as a single-use system, meaning each component is intended for one patient and one procedure only. It is not designed for reuse, reprocessing, or resterilization, and should be discarded after use to ensure patient safety and device integrity.

  • What regulatory authorization does the SETx Pedicle Screw System have?

    The SETx Pedicle Screw System is authorized under FDA 510(k) clearance with K number K170611. It was determined to be substantially equivalent to a predicate device and received traditional clearance on May 25, 2017, following submission on March 1, 2017.