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Zeta Multizone Scn Locking Nail

by Howmedica Corp.

510(k) K982873

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 NumberK982873 Date21 Oct 1998ClearedStatusActive

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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Zeta Multizon SCN Locking Nail is an intramedullary nail intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the distal femur, including the supracondylar region. It is designed for use in orthopedic procedures to stabilize femoral fractures.

The device is supplied as part of a locking nail system that includes intramedullary nails, screws, and end caps, fabricated from titanium alloy or stainless steel. It is inserted via open or closed surgical techniques and features proximal and distal holes for cross-locking. The device received FDA 510(k) clearance under K982873 and is classified under product code HSB with an orthopedic advisory committee review.

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Questions

AI-generated answers, 24 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 Zeta Multizon SCN Locking Nail used for?

    The Zeta Multizon SCN Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions, and nonunions of the distal femur, including the supracondylar region, in orthopedic procedures.

  • How is the Zeta Multizon SCN Locking Nail supplied and what materials is it made from?

    The device is supplied as part of a locking nail system that includes intramedullary nails, screws, and end caps, all fabricated from titanium alloy or stainless steel.

  • What surgical techniques can be used to insert the Zeta Multizon SCN Locking Nail?

    The device is inserted via open or closed surgical techniques, allowing flexibility based on the surgeon's approach and patient anatomy.

  • Does the Zeta Multizon SCN Locking Nail have locking capabilities, and how are they achieved?

    Yes, the device features proximal and distal holes designed for cross-locking, enabling secure fixation when used with compatible screws from the system.