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Headloc Ceramic Head

by Ortho Development Corp. 2 variants

510(k) K971426

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK971426 Date9 Jul 1997DecidedStatusActive

Official records

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  • Withdrawn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
SN

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 Headloc Ceramic Head is a zirconia ceramic femoral head intended for use in hip arthroplasty systems. It is designed as a component of the Primaloc Cementless Hip System for implantation in primary or revision surgery.

The device is supplied as a single-use implant and is intended for cementless implantation. It is regulated under FDA 510(k) clearance K971426 with product code LZO and is classified as a Class II medical device.

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