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FDA 510(k)

PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,

K-Number: K000515 · 2000-09-15

ApplicantInterpore Cross Intl.
Decision Date2000-09-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, is the device name listed in this FDA 510(k) record. The listed applicant is Interpore Cross Intl.. It received FDA 510(k) clearance on 2000-09-15 under 510(k) number K000515. 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 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,?

PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, is a medical device that received FDA 510(k) clearance on 2000-09-15. The listed applicant is Interpore Cross Intl.. The 510(k) number is K000515.

When did PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, receive FDA 510(k) clearance?

PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, received FDA 510(k) clearance on 2000-09-15, under 510(k) number K000515.

Who is the listed applicant for PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,?

The FDA 510(k) record lists Interpore Cross Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,?

The FDA product code for PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, is MQV.

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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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