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FDA 510(k)

CSCO FOREHEAD FIXATION SYSTEM

K-Number: K963502 · 1997-10-28

ApplicantHowmedica Corp.
Decision Date1997-10-28
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CSCO FOREHEAD FIXATION 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 1997-10-28 under 510(k) number K963502. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSCO FOREHEAD FIXATION SYSTEM?

CSCO FOREHEAD FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-28. The listed applicant is Howmedica Corp.. The 510(k) number is K963502.

When did CSCO FOREHEAD FIXATION SYSTEM receive FDA 510(k) clearance?

CSCO FOREHEAD FIXATION SYSTEM received FDA 510(k) clearance on 1997-10-28, under 510(k) number K963502.

Who is the listed applicant for CSCO FOREHEAD FIXATION 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 CSCO FOREHEAD FIXATION SYSTEM?

The FDA product code for CSCO FOREHEAD FIXATION SYSTEM is MBI.

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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: MBI)

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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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