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FDA 510(k)

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS

K-Number: K051614 · 2005-09-09

ApplicantLifecore Biomedical, Inc.
Decision Date2005-09-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 2005-09-09 under 510(k) number K051614. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS?

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K051614.

When did PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS receive FDA 510(k) clearance?

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS received FDA 510(k) clearance on 2005-09-09, under 510(k) number K051614.

Who is the listed applicant for PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS?

The FDA 510(k) record lists Lifecore Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS?

The FDA product code for PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS is DZE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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