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FDA 510(k)

ULTIMAX CORTICAL BONE SCREWS

K-Number: K990513 · 1999-03-17

ApplicantBiodynamic Technologies, Inc.
Decision Date1999-03-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMAX CORTICAL BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamic Technologies, Inc.. It received FDA 510(k) clearance on 1999-03-17 under 510(k) number K990513. 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 ULTIMAX CORTICAL BONE SCREWS?

ULTIMAX CORTICAL BONE SCREWS is a medical device that received FDA 510(k) clearance on 1999-03-17. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K990513.

When did ULTIMAX CORTICAL BONE SCREWS receive FDA 510(k) clearance?

ULTIMAX CORTICAL BONE SCREWS received FDA 510(k) clearance on 1999-03-17, under 510(k) number K990513.

Who is the listed applicant for ULTIMAX CORTICAL BONE SCREWS?

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

What is the FDA product code for ULTIMAX CORTICAL BONE SCREWS?

The FDA product code for ULTIMAX CORTICAL BONE SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Biodynamic Technologies, 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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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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