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FDA 510(k)

BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID

K-Number: K041616 · 2004-08-25

ApplicantOrthos (Uk) Limited
Decision Date2004-08-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID is the device name listed in this FDA 510(k) record. The listed applicant is Orthos (Uk) Limited. It received FDA 510(k) clearance on 2004-08-25 under 510(k) number K041616. 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 BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID?

BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is Orthos (Uk) Limited. The 510(k) number is K041616.

When did BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID receive FDA 510(k) clearance?

BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID received FDA 510(k) clearance on 2004-08-25, under 510(k) number K041616.

Who is the listed applicant for BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID?

The FDA 510(k) record lists Orthos (Uk) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID?

The FDA product code for BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID 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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