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FDA 510(k)

AME UNIVERSAL BONE SCREW

K-Number: K930107 · 1994-02-22

ApplicantAmerican Medical Electronics, Inc.
Decision Date1994-02-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AME UNIVERSAL BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Electronics, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K930107. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AME UNIVERSAL BONE SCREW?

AME UNIVERSAL BONE SCREW is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is American Medical Electronics, Inc.. The 510(k) number is K930107.

When did AME UNIVERSAL BONE SCREW receive FDA 510(k) clearance?

AME UNIVERSAL BONE SCREW received FDA 510(k) clearance on 1994-02-22, under 510(k) number K930107.

Who is the listed applicant for AME UNIVERSAL BONE SCREW?

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

What is the FDA product code for AME UNIVERSAL BONE SCREW?

The FDA product code for AME UNIVERSAL BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing American Medical Electronics, 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.

K951232EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MMK952348OGDEN ANCHORK950875OGDEN ANCHORK951493OGDEN ANCHORK951545OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONSK941029OGDEN ANCHOR-SMALL (TENTATIVE)

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Related Devices (Code: HWC)

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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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