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FDA 510(k)

BRIGHAM TIBIAL CEMENT PRESSURIZER

K-Number: K833675 · 1983-12-12

ApplicantHowmedica Corp.
Decision Date1983-12-12
Product CodeKIH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BRIGHAM TIBIAL CEMENT PRESSURIZER is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1983-12-12 under 510(k) number K833675. The device is classified under product code KIH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRIGHAM TIBIAL CEMENT PRESSURIZER?

BRIGHAM TIBIAL CEMENT PRESSURIZER is a medical device that received FDA 510(k) clearance on 1983-12-12. The listed applicant is Howmedica Corp.. The 510(k) number is K833675.

When did BRIGHAM TIBIAL CEMENT PRESSURIZER receive FDA 510(k) clearance?

BRIGHAM TIBIAL CEMENT PRESSURIZER received FDA 510(k) clearance on 1983-12-12, under 510(k) number K833675.

Who is the listed applicant for BRIGHAM TIBIAL CEMENT PRESSURIZER?

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 BRIGHAM TIBIAL CEMENT PRESSURIZER?

The FDA product code for BRIGHAM TIBIAL CEMENT PRESSURIZER is KIH.

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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: KIH)

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.

K042591SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.K943906P.F.C. CEMENT PRESSURIZING SYSTEMJohnson & Johnson Professionals, Inc.K897134CMW CEMENT PRESSURISATION SYSTEMDentsply Intl.K851881ORTHOPEADIC CEMENT DELIVERY SYSTEMDentsply Intl.K840046PRESSURIZING/SCAVENGING ACRYLIC CEMENTPrecision Medical Devices, Inc.K811317HOWMEDICA FEMORAL PRESSURING SEALHowmedica 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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