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Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical

by Medical Facets

510(k) K112727

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 NumberK112727 Date13 Jan 2012ClearedStatusActive

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  • Withdrawn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
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 device is a set of orthopedic screws including corical, cancellous, and headless compression screws manufactured by Medical Facets. These are implantable fixation devices intended for use in bone stabilization procedures.

The device was cleared through the FDA 510(k) process under K112727 with product code HWC and is classified as substantially equivalent to a predicate device. It is supplied non-sterile and intended for single-use application in orthopedic surgical settings.

Questions

AI-generated answers, 23 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 Medical Facets screw set used for?

    The Medical Facets screw set is intended for use in bone stabilization procedures as implantable fixation devices. It includes corical, cancellous, and headless compression screws designed to stabilize bone during orthopedic surgical settings.

  • How is the Medical Facets screw set supplied and is it reusable?

    The device is supplied non-sterile and intended for single-use application only. It should not be reused due to risks of contamination, material degradation, or compromised mechanical integrity after initial implantation.

  • What regulatory pathway was used for the Medical Facets screw set clearance?

    The device was cleared through the FDA 510(k) process under submission K112727, where it was determined to be substantially equivalent to a predicate device with product code HWC in the orthopedic panel.