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FDA 510(k)

HOWMEDICA KINEMATIC II TIBIAL WEDGE

K-Number: K842367 · 1984-08-17

ApplicantHowmedica Corp.
Decision Date1984-08-17
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA KINEMATIC II TIBIAL WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K842367. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOWMEDICA KINEMATIC II TIBIAL WEDGE?

HOWMEDICA KINEMATIC II TIBIAL WEDGE is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Howmedica Corp.. The 510(k) number is K842367.

When did HOWMEDICA KINEMATIC II TIBIAL WEDGE receive FDA 510(k) clearance?

HOWMEDICA KINEMATIC II TIBIAL WEDGE received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842367.

Who is the listed applicant for HOWMEDICA KINEMATIC II TIBIAL WEDGE?

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 KINEMATIC II TIBIAL WEDGE?

The FDA product code for HOWMEDICA KINEMATIC II TIBIAL WEDGE is HRY.

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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: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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