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Zimmer Ceramic Femoral Heads 28MM Diameter

by Zimmer, Inc.

510(k) K914676

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 NumberK914676 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  • Withdrawn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)

Full name
Zimmer(R) Ceramic Femoral Heads 28mm Diameter
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, 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 Zimmer Ceramic Femoral Heads 28mm Diameter are ceramic components designed for use as part of a total hip or hemi-hip prosthesis. These femoral heads are intended to articulate with acetabular components, providing a smooth, low-friction bearing surface to improve joint mobility and durability in orthopedic applications.

These devices are supplied sterile and intended for single-use in surgical procedures. They are regulated under FDA 510(k) clearance (K914676) and are classified under the traditional review pathway. The 28mm diameter size is specified for compatibility with corresponding hip implants, and proper storage conditions must be maintained to preserve sterility and performance.

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