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FDA 510(k)

FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM

K-Number: K935646 · 1994-03-09

ApplicantBiodynamic Technologies, Inc.
Decision Date1994-03-09
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

FX-CABLELOK(TM) STOP(TROCHANTER HOOK) 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 1994-03-09 under 510(k) number K935646. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM?

FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K935646.

When did FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM receive FDA 510(k) clearance?

FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM received FDA 510(k) clearance on 1994-03-09, under 510(k) number K935646.

Who is the listed applicant for FX-CABLELOK(TM) STOP(TROCHANTER HOOK) 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 FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM?

The FDA product code for FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM is JDQ.

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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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