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Exactech Ceramic Femoral Head Component

by Exactech, Inc.

510(k) K914574

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 NumberK914574 Date13 Jan 1992ClearedStatusActive

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Exactech Ceramic Femoral Head Component is a medical device designed for use in orthopedic procedures. It is a spherical ceramic head made of aluminum oxide (A12O3) that attaches to the proximal end of a femoral stem, ensuring positive locking with the tapered surface of the stem.

This device is supplied as a single-use component and is regulated under FDA 510(k) clearance with product code LZO. It is manufactured by Exactech, Inc. in Gainesville, US, and is intended for use in orthopedic applications. The device is not MRI safe and should be stored according to manufacturer instructions.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Questions

AI-generated answers, 25 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 Exactech Ceramic Femoral Head Component used for?

    The Exactech Ceramic Femoral Head Component is designed for orthopedic procedures. It is a spherical ceramic head made of aluminum oxide that attaches to the proximal end of a femoral stem, ensuring positive locking with the tapered surface of the stem.

  • Is the Exactech Ceramic Femoral Head Component reusable or single-use?

    The Exactech Ceramic Femoral Head Component is supplied as a single-use component. It is not designed for reuse and should be discarded after a single surgical procedure according to medical waste disposal guidelines.

  • What are the storage requirements for the Exactech Ceramic Femoral Head Component?

    The Exactech Ceramic Femoral Head Component should be stored according to manufacturer instructions. It is important to note that this device is not MRI safe, so proper storage should ensure it is not exposed to MRI environments.

  • What regulatory approval does the Exactech Ceramic Femoral Head Component have?

    The Exactech Ceramic Femoral Head Component is regulated under FDA 510(k) clearance with product code LZO. It received clearance on January 13, 1992, with decision code SESE, indicating it was found to be substantially equivalent to predicate devices.