Parke-Davis Total Hip Prosthesis

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K791875 ↗

FDA Product Code

DXQ

Device Class

Class II

Regulation

21 CFR Part 870.1120

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• General Diagnostics Coag-a-Mate Xc

  Class I

  FDA 510(k) K852843 Active Cleared 13 Aug 1985

• Chick Surgical Table

  Class I

  FDA 510(k) K800118 Active Cleared 5 Feb 1980

• A O Microscope Video System

  Class I

  FDA 510(k) K821865 Active Cleared 14 Jul 1982

• Deseret Angio Guide

  Class II

  FDA 510(k) K821577 Active Cleared 16 Jun 1982

• A O Histostat Embedding Ctr #8030, 32, 34

  Class I

  FDA 510(k) K821831 Active Cleared 13 Jul 1982

• Deseret Capacity Plus Electrosurg. Pad

  Class II

  FDA 510(k) K821356 Active Cleared 14 Jul 1982

See all devices from Warner-Lambert Co. →

• What is the Parke-Davis Total Hip Prosthesis used for?

  It is designed for total hip replacement procedures to replace a damaged or diseased natural hip joint, restoring mobility and function in patients with hip conditions.

• Is the Parke-Davis Total Hip Prosthesis supplied sterile and for single use only?

  Yes, it is supplied as a single-use implant and must be implanted using appropriate surgical techniques; it is not intended for reuse after implantation.

• What sizes are available for the Parke-Davis Total Hip Prosthesis?

  The device is available in various sizes to accommodate different patient anatomies, though specific size dimensions are not detailed in the provided data.

• How should the Parke-Davis Total Hip Prosthesis be stored?

  It should be stored under standard conditions, as indicated in the device description, to maintain integrity prior to surgical use.

• What regulatory pathway was used for the Parke-Davis Total Hip Prosthesis?

  It received FDA 510(k) clearance under K number K791875, indicating it was found substantially equivalent to a legally marketed predicate device.