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FDA 510(k)

SMALL BONE FIXATION SYSTEM

K-Number: K911929 · 1991-07-02

ApplicantUnited American Medical Co., Inc.
Decision Date1991-07-02
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMALL BONE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is United American Medical Co., Inc.. It received FDA 510(k) clearance on 1991-07-02 under 510(k) number K911929. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMALL BONE FIXATION SYSTEM?

SMALL BONE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-07-02. The listed applicant is United American Medical Co., Inc.. The 510(k) number is K911929.

When did SMALL BONE FIXATION SYSTEM receive FDA 510(k) clearance?

SMALL BONE FIXATION SYSTEM received FDA 510(k) clearance on 1991-07-02, under 510(k) number K911929.

Who is the listed applicant for SMALL BONE FIXATION SYSTEM?

The FDA 510(k) record lists United American Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMALL BONE FIXATION SYSTEM?

The FDA product code for SMALL BONE FIXATION SYSTEM is HWE.

Related Clinical Trials

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Other records listing United American Medical Co., 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.

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Related Devices (Code: HWE)

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

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