Skip to content

Intramedullary Nail

by The Deca Co.

510(k) K870040

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 NumberK870040 Date26 Mar 1987ClearedStatusActive

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  • Withdrawn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 Intramedullary Nail is an orthopedic device used for fracture fixation, providing mechanical fixation of metaphyseal or diaphyseal fractures. It is a metal nail introduced into the medullary canal of a bone. The device is used to stabilize and align fractures, allowing for proper healing.

The Intramedullary Nail is supplied as a single device and is intended for use in orthopedic procedures. It is available with a product code of HSB and has been authorized with an FDA 510K clearance. The device is used in various sizes and is typically used in a surgical setting, with the nailing procedure performed either antegrade or retrograde.

Other devices from The Deca Co.

See all devices from The Deca Co. →