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FDA 510(k)

EBI DYNAFIX COMPRESSION BONE SCREW

K-Number: K030706 · 2003-03-20

ApplicantEbi, L.P.
Decision Date2003-03-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI DYNAFIX COMPRESSION BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K030706. 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 EBI DYNAFIX COMPRESSION BONE SCREW?

EBI DYNAFIX COMPRESSION BONE SCREW is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Ebi, L.P.. The 510(k) number is K030706.

When did EBI DYNAFIX COMPRESSION BONE SCREW receive FDA 510(k) clearance?

EBI DYNAFIX COMPRESSION BONE SCREW received FDA 510(k) clearance on 2003-03-20, under 510(k) number K030706.

Who is the listed applicant for EBI DYNAFIX COMPRESSION BONE SCREW?

The FDA 510(k) record lists Ebi, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBI DYNAFIX COMPRESSION BONE SCREW?

The FDA product code for EBI DYNAFIX COMPRESSION BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Ebi, L.P. as applicant

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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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