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FDA 510(k)

PRO OSTEON 500R

K-Number: K063346 · 2007-04-18

ApplicantEbi, L.P.
Decision Date2007-04-18
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO OSTEON 500R 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 2007-04-18 under 510(k) number K063346. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO OSTEON 500R?

PRO OSTEON 500R is a medical device that received FDA 510(k) clearance on 2007-04-18. The listed applicant is Ebi, L.P.. The 510(k) number is K063346.

When did PRO OSTEON 500R receive FDA 510(k) clearance?

PRO OSTEON 500R received FDA 510(k) clearance on 2007-04-18, under 510(k) number K063346.

Who is the listed applicant for PRO OSTEON 500R?

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 PRO OSTEON 500R?

The FDA product code for PRO OSTEON 500R is MQV.

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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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