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FDA 510(k)

FOREFOOT RECONSTRUCTION SYSTEM

K-Number: K961485 · 1996-06-01

ApplicantHowmedica Corp.
Decision Date1996-06-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOREFOOT RECONSTRUCTION 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 1996-06-01 under 510(k) number K961485. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOREFOOT RECONSTRUCTION SYSTEM?

FOREFOOT RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-01. The listed applicant is Howmedica Corp.. The 510(k) number is K961485.

When did FOREFOOT RECONSTRUCTION SYSTEM receive FDA 510(k) clearance?

FOREFOOT RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 1996-06-01, under 510(k) number K961485.

Who is the listed applicant for FOREFOOT RECONSTRUCTION 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 FOREFOOT RECONSTRUCTION SYSTEM?

The FDA product code for FOREFOOT RECONSTRUCTION SYSTEM is HRS.

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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: HRS)

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.

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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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