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FDA 510(k)

DURACON(R) SMALL STABILIZER TIBIAL INSERT

K-Number: K974843 · 1998-06-18

ApplicantHowmedica Corp.
Decision Date1998-06-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DURACON(R) SMALL STABILIZER TIBIAL INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-06-18 under 510(k) number K974843. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DURACON(R) SMALL STABILIZER TIBIAL INSERT?

DURACON(R) SMALL STABILIZER TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 1998-06-18. The listed applicant is Howmedica Corp.. The 510(k) number is K974843.

When did DURACON(R) SMALL STABILIZER TIBIAL INSERT receive FDA 510(k) clearance?

DURACON(R) SMALL STABILIZER TIBIAL INSERT received FDA 510(k) clearance on 1998-06-18, under 510(k) number K974843.

Who is the listed applicant for DURACON(R) SMALL STABILIZER TIBIAL INSERT?

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 DURACON(R) SMALL STABILIZER TIBIAL INSERT?

The FDA product code for DURACON(R) SMALL STABILIZER TIBIAL INSERT is JWH.

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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: JWH)

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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