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FDA 510(k)

HOWMEDICA HNR SYSTEM

K-Number: K903563 · 1991-03-14

ApplicantHowmedica Corp.
Decision Date1991-03-14
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA HNR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1991-03-14 under 510(k) number K903563. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWMEDICA HNR SYSTEM?

HOWMEDICA HNR SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-14. The listed applicant is Howmedica Corp.. The 510(k) number is K903563.

When did HOWMEDICA HNR SYSTEM receive FDA 510(k) clearance?

HOWMEDICA HNR SYSTEM received FDA 510(k) clearance on 1991-03-14, under 510(k) number K903563.

Who is the listed applicant for HOWMEDICA HNR SYSTEM?

The FDA 510(k) record lists Howmedica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOWMEDICA HNR SYSTEM?

The FDA product code for HOWMEDICA HNR SYSTEM is LWJ.

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Other records listing Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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