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FDA 510(k)

BTI CORTICAL BONE SCREWS

K-Number: K972403 · 1997-08-29

ApplicantBiodynamic Technologies, Inc.
Decision Date1997-08-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BTI 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 1997-08-29 under 510(k) number K972403. 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 BTI CORTICAL BONE SCREWS?

BTI CORTICAL BONE SCREWS is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K972403.

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

BTI CORTICAL BONE SCREWS received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972403.

Who is the listed applicant for BTI 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 BTI CORTICAL BONE SCREWS?

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

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Other records listing Biodynamic Technologies, Inc. as applicant

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Related Devices (Code: HWC)

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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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