Skip to content

5.0 Mm Diameter Polyaxial Screws (Moss Miami 6.35MM System)

by Depuyacromed

510(k) K022623

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 NumberK022623 Date27 Aug 2002ClearedStatusActive

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  • Withdrawn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, 21 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 5.0 Mm Diameter Polyaxial Screws (Moss Miami 6.35mm System) is a spinal fixation device that provides mechanical stabilization of vertebral segments to facilitate fusion. It is used for posterior/anterior spinal fixation and is operated by surgeons in clinical/OR settings. The device is implanted into pedicles or sacral/iliac regions to anchor spinal constructs.

The device is supplied as part of the Moss Miami 6.35mm spinal system and is available in 5.0mm diameter. It has been cleared under FDA 510K, with the product code KWP, and is classified as a Class II device with special controls. The device is intended for single use and is sterilized prior to use.

Other devices from Depuyacromed

See all devices from Depuyacromed →

Questions

AI-generated answers, 21 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 is the intended use of the 5.0mm Diameter Polyaxial Screws?

    The screws are intended for posterior/anterior spinal fixation to provide mechanical stabilization of vertebral segments and facilitate fusion.

  • How is the device supplied and sterilized?

    The device is supplied as part of the Moss Miami 6.35mm spinal system and is sterilized prior to use, intended for single use.

  • What are the specifications of the Polyaxial Screws?

    The device is available in 5.0mm diameter and is classified as a Class II device with special controls.