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FDA 510(k)

BTI HUMERAL INTRAMEDULLARY ROD SYSTEM

K-Number: K980102 · 1998-04-03

ApplicantBiodynamic Technologies, Inc.
Decision Date1998-04-03
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BTI HUMERAL INTRAMEDULLARY ROD SYSTEM 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 1998-04-03 under 510(k) number K980102. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTI HUMERAL INTRAMEDULLARY ROD SYSTEM?

BTI HUMERAL INTRAMEDULLARY ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K980102.

When did BTI HUMERAL INTRAMEDULLARY ROD SYSTEM receive FDA 510(k) clearance?

BTI HUMERAL INTRAMEDULLARY ROD SYSTEM received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980102.

Who is the listed applicant for BTI HUMERAL INTRAMEDULLARY ROD SYSTEM?

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 HUMERAL INTRAMEDULLARY ROD SYSTEM?

The FDA product code for BTI HUMERAL INTRAMEDULLARY ROD SYSTEM is HSB.

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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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