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Xia Stainless Steel Spinal System

by Stryker Spine

510(k) K063428

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 NumberK063428 Date11 Dec 2006ClearedStatusActive

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  • Withdrawn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, 20 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 Xia Stainless Steel Spinal System is a spinal fixation device classified as a spinal fixation device under the FDA’s orthopedic nomenclature. It consists of pedicle screws, rods, and connecting hardware designed to stabilize the spine through internal fixation, addressing degenerative, trauma, tumor, and deformity pathologies. Constructed from stainless steel, the system provides mechanical support to the vertebral column, facilitating surgical interventions such as spinal fusion. Its modular design allows for intraoperative flexibility in surgical planning and adaptation to varying anatomical requirements.

This system is supplied as a reusable surgical implant, intended for use in controlled operating room environments by trained orthopedic surgeons. The stainless steel components are non-magnetic and MRI-safe for postoperative imaging, though precautions should be taken to avoid interference with MRI equipment. The system is available in standardized screw lengths and rod diameters, with compatibility for both anterior and posterior spinal approaches. It is regulated under FDA 510(k) clearance (K063428) as substantially equivalent to predicate devices, adhering to orthopedic surgical standards for spinal stabilization.

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