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FDA 510(k)

EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM

K-Number: K962552 · 1996-09-25

ApplicantBiodynamic Technologies, Inc.
Decision Date1996-09-25
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY 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 1996-09-25 under 510(k) number K962552. 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 EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM?

EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-25. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K962552.

When did EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM receive FDA 510(k) clearance?

EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM received FDA 510(k) clearance on 1996-09-25, under 510(k) number K962552.

Who is the listed applicant for EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY 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 EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM?

The FDA product code for EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY 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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