K864508Substantially Equivalent

Howse II Total Hip Replacement System

Name: K864508 Howse II Total Hip Replacement System
Creator: Johnson & Johnson Professionals, Inc.
Published: 1986-12-09
License: https://open.fda.gov/license/

Johnson & Johnson Professionals, Inc., England, GB / Traditional, Substantially Equivalent

FDA source

K864508 is the FDA 510(k) clearance record for HOWSE II TOTAL HIP REPLACEMENT SYSTEM, cleared for Johnson & Johnson Professionals, Inc. on 1986-12-09. FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from 1976-07-20 to 2000-04-07. As of 2026-09-10, FDA records show no recalls naming K864508.

Clearance record

Decision date: 1986-12-09
Received: 1986-11-14 (25 days to decision)
Review panel: Unknown
Applicant: Johnson & Johnson Professionals, Inc. Brunel Way, England, GB
Third party review: No