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FDA 510(k)

DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE

K-Number: K945294 · 1995-03-07

ApplicantHowmedica Corp.
Decision Date1995-03-07
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K945294. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE?

DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Howmedica Corp.. The 510(k) number is K945294.

When did DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE receive FDA 510(k) clearance?

DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE received FDA 510(k) clearance on 1995-03-07, under 510(k) number K945294.

Who is the listed applicant for DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE?

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 DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE?

The FDA product code for DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE is JDQ.

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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: JDQ)

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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