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SSP Pedicle Screw System

by Specialty Spine Products, LLC

510(k) K060118

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 NumberK060118 Date8 Jun 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  • Withdrawn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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
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 SSP Pedicle Screw System is an internal fixation device for spinal surgery that includes pedicle screws, rods, and transverse links to provide segmental fixation. It is designed to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion for acute or chronic instability and deformity of the thoracic, lumbar, and sacral spine.

The system is supplied with screws and rods available in multiple lengths, diameters, and contours to match patient anatomy. It is cleared in the United States through an FDA 510(k) submission (K060118) as substantially equivalent to a predicate device.

Other devices from Specialty Spine Products, LLC

Questions

AI-generated answers, 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.

  • What clinical situations is the SSP Pedicle Screw System intended for?

    It is designed to immobilize and stabilize thoracic, lumbar, and sacral spinal segments in skeletally mature patients who need adjunctive fixation for acute or chronic instability or deformity, typically as part of a fusion procedure.

  • How are the screws and rods supplied to match patient anatomy?

    The system includes a range of screw lengths, diameters, and rod contours, allowing the surgeon to select components that best fit the individual patient's vertebral dimensions and desired curvature, ensuring optimal fixation and alignment.

  • Is the SSP Pedicle Screw System a single‑use or reusable device?

    The device is supplied as a complete internal fixation system intended for single surgical implantation. Once implanted, the screws, rods, and transverse links remain in the patient permanently and are not removed for reuse.

  • What regulatory pathway was used for the SSP Pedicle Screw System in the United States?

    The system received clearance through a traditional FDA 510(k) submission (K060118), demonstrating substantial equivalence to a predicate device, and was reviewed by the Orthopedic advisory committee.