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FDA 510(k)

MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA

K-Number: K914043 · 1991-12-09

Decision Date1991-12-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Implant Sales, Inc.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K914043. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA?

MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Midwest Implant Sales, Inc.. The 510(k) number is K914043.

When did MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA receive FDA 510(k) clearance?

MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914043.

Who is the listed applicant for MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA?

The FDA 510(k) record lists Midwest Implant Sales, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA?

The FDA product code for MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA is DZE.

Related Clinical Trials

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.

Other records listing Midwest Implant Sales, Inc. 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.

Related Devices (Code: DZE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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