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Ace Humeral Nail

by Ace Orthopedic Manufacturing Co.

510(k) K934643

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 NumberK934643 Date22 Mar 1994ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a rod, fixation, intramedullary and accessory, classified under product code HSB and intended for orthopedic use. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The Ace Humeral Nail was manufactured by Ace Orthopedic Manufacturing Co., located at 14105 S. Avalon Blvd., Los Angeles, CA 90061. It received FDA 510(k) clearance K934643 on March 22, 1994, following submission on September 29, 1993.

Other devices from Ace Orthopedic Manufacturing Co.

See all devices from Ace Orthopedic Manufacturing Co. →

Questions

AI-generated answers, 1 Oct 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 Ace Humeral Nail used for?

    The Ace Humeral Nail is intended for orthopedic use as an intramedullary fixation rod to stabilize humeral fractures, based on its classification under product code HSB and its 510(k) clearance as substantially equivalent to a predicate device.

  • How was the Ace Humeral Nail cleared for market?

    The Ace Humeral Nail received FDA 510(k) clearance through the traditional pathway, identified as K934643, after being found substantially equivalent to a legally marketed device, following submission on September 29, 1993 and clearance on March 22, 1994.

  • Who manufactures the Ace Humeral Nail and where is it made?

    The Ace Humeral Nail is manufactured by Ace Orthopedic Manufacturing Co., located at 14105 S. Avalon Blvd., Los Angeles, CA 90061, as specified in the device’s authorization and address details.