Skip to content

K-Fix

by New Deal, S.A.

510(k) K022597

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 NumberK022597 Date1 Nov 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  • Withdrawn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
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 K-FIX Wire Protecting Caps are classified as orthopedic devices designed to protect protruding wire ends. These caps are intended for use in orthopedic procedures, including osteotomies, arthrodesis, and fracture management in the foot or hand, as well as for securing small bone fragments during fixation.

These caps are supplied as single-use devices and are regulated under the FDA’s 510(k) clearance process, classified under product code HTY. They are intended for use in orthopedic settings and must be handled in accordance with sterile medical device protocols. No additional regulatory status beyond the stated FDA clearance is implied.

Other devices from New Deal, S.A.

See all devices from New Deal, S.A. →