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FDA 510(k)

HOWSE II TOTAL HIP REPLACEMENT SYSTEM

K-Number: K864508 · 1986-12-09

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1986-12-09
Product Code
DecisionSubstantially Equivalent

Device Summary

HOWSE II TOTAL HIP REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1986-12-09 under 510(k) number K864508. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWSE II TOTAL HIP REPLACEMENT SYSTEM?

HOWSE II TOTAL HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1986-12-09. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K864508.

When did HOWSE II TOTAL HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

HOWSE II TOTAL HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 1986-12-09, under 510(k) number K864508.

Who is the listed applicant for HOWSE II TOTAL HIP REPLACEMENT SYSTEM?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992173SIPHONGUARD CSF CONTROL DEVICEK991413CODMAN ETHISORB DURA PATCHK991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITK982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERK982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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