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FDA 510(k)

PLEXUR-P

K-Number: K080511 · 2008-04-21

ApplicantOsteotech, Inc.
Decision Date2008-04-21
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLEXUR-P is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 2008-04-21 under 510(k) number K080511. 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 PLEXUR-P?

PLEXUR-P is a medical device that received FDA 510(k) clearance on 2008-04-21. The listed applicant is Osteotech, Inc.. The 510(k) number is K080511.

When did PLEXUR-P receive FDA 510(k) clearance?

PLEXUR-P received FDA 510(k) clearance on 2008-04-21, under 510(k) number K080511.

Who is the listed applicant for PLEXUR-P?

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

What is the FDA product code for PLEXUR-P?

The FDA product code for PLEXUR-P is MQV.

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Other records listing Osteotech, Inc. as applicant

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Related Devices (Code: 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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