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FDA 510(k)

NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX

K-Number: K072363 · 2008-01-31

ApplicantBiomet 3i, Inc.
Decision Date2008-01-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, Inc.. It received FDA 510(k) clearance on 2008-01-31 under 510(k) number K072363. 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 NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX?

NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX is a medical device that received FDA 510(k) clearance on 2008-01-31. The listed applicant is Biomet 3i, Inc.. The 510(k) number is K072363.

When did NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX receive FDA 510(k) clearance?

NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX received FDA 510(k) clearance on 2008-01-31, under 510(k) number K072363.

Who is the listed applicant for NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX?

The FDA 510(k) record lists Biomet 3i, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX?

The FDA product code for NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX is DZE.

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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