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FDA 510(k)

BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS

K-Number: K974756 · 1998-03-12

ApplicantBiodynamic Technologies, Inc.
Decision Date1998-03-12
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BTI LARGE (7.0MM) CANNULATED TRANSFIXING 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 1998-03-12 under 510(k) number K974756. 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 for Some Indications.

Frequently Asked Questions

What is the BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS?

BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS is a medical device that received FDA 510(k) clearance on 1998-03-12. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K974756.

When did BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS receive FDA 510(k) clearance?

BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS received FDA 510(k) clearance on 1998-03-12, under 510(k) number K974756.

Who is the listed applicant for BTI LARGE (7.0MM) CANNULATED TRANSFIXING 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 LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS?

The FDA product code for BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS is HWC. This falls under the Cardiovascular category.

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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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