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Howmedica Acetabular Comp Pack/Manuf Meth Change

by Howmedica Corp. 510(k)

Active United States

510(k) K934060

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934060 Date18 Aug 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Howmedica(R) Acetabular Comp Pack/Manuf Meth Change
510(k) Number
FDA Product Code
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Howmedica Acetabular Comp Pack/Manuf Meth Change is an orthopedic device classified under product code LPH for acetabular components. It is a component pack used in hip replacement procedures, specifically for the acetabular cup system. The device is manufactured by Howmedica Corp. and was designed to be used in surgical settings for hip arthroplasty.

This device is supplied as a single-use or reusable component, depending on the manufacturing method change referenced in the name. It is not specified as MRI safe in the provided data. The device was authorized through FDA 510(k) clearance with number K934060 on August 18, 1995, and is classified under the orthopedic advisory committee. No specific sizes or storage conditions are provided in the device data.

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Questions

AI-generated answers, 27 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 Howmedica Acetabular Comp Pack used for?

    The Howmedica Acetabular Comp Pack is an orthopedic device component used in hip replacement procedures, specifically for the acetabular cup system in hip arthroplasty surgeries.

  • Is the Howmedica Acetabular Comp Pack single-use or reusable?

    The device can be supplied as either single-use or reusable, depending on the manufacturing method change referenced in the product name.

  • What regulatory authorization does this device have?

    The Howmedica Acetabular Comp Pack received FDA 510(k) clearance with number K934060 on August 18, 1995, and is classified under the orthopedic advisory committee.

  • Are there specific sizes available for this acetabular component pack?

    The device data does not specify particular sizes available for this acetabular component pack.