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FDA 510(k)

EZ-FIX SMALL CANNULATED SCREW SYSTEM

K-Number: K962987 · 1996-11-04

ApplicantBiodynamic Technologies, Inc.
Decision Date1996-11-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EZ-FIX SMALL CANNULATED SCREW 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 1996-11-04 under 510(k) number K962987. 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.

Frequently Asked Questions

What is the EZ-FIX SMALL CANNULATED SCREW SYSTEM?

EZ-FIX SMALL CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-04. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K962987.

When did EZ-FIX SMALL CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

EZ-FIX SMALL CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 1996-11-04, under 510(k) number K962987.

Who is the listed applicant for EZ-FIX SMALL CANNULATED SCREW 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-FIX SMALL CANNULATED SCREW SYSTEM?

The FDA product code for EZ-FIX SMALL CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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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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