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FDA 510(k)

PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT

K-Number: K072597 · 2007-10-15

ApplicantWrightmedicaltechnologyinc
Decision Date2007-10-15
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2007-10-15 under 510(k) number K072597. 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-DENSE CORE DECOMPRESSION PROCEDURE KIT?

PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2007-10-15. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K072597.

When did PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT receive FDA 510(k) clearance?

PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT received FDA 510(k) clearance on 2007-10-15, under 510(k) number K072597.

Who is the listed applicant for PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT?

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

What is the FDA product code for PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT?

The FDA product code for PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT 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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