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FDA 510(k)

QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM

K-Number: K953264 · 1995-10-20

ApplicantWrightmedicaltechnologyinc
Decision Date1995-10-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1995-10-20 under 510(k) number K953264. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM?

QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K953264.

When did QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM receive FDA 510(k) clearance?

QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM received FDA 510(k) clearance on 1995-10-20, under 510(k) number K953264.

Who is the listed applicant for QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM?

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 QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM?

The FDA product code for QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM is MBI.

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Related Devices (Code: MBI)

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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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