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FDA 510(k)

BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM

K-Number: K970897 · 1997-04-21

ApplicantBiodynamic Technologies, Inc.
Decision Date1997-04-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BTI DISTAL FEMORAL 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 1997-04-21 under 510(k) number K970897. 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 DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM?

BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K970897.

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

BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970897.

Who is the listed applicant for BTI DISTAL FEMORAL 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 DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM?

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

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Related Devices (Code: 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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