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FDA 510(k)

MectaScrew PEEK Interference Screw

K-Number: K190892 · 2019-06-04

ApplicantMedacta International S.A.
Decision Date2019-06-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaScrew PEEK Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2019-06-04 under 510(k) number K190892. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaScrew PEEK Interference Screw?

MectaScrew PEEK Interference Screw is a medical device that received FDA 510(k) clearance on 2019-06-04. The listed applicant is Medacta International S.A.. The 510(k) number is K190892.

When did MectaScrew PEEK Interference Screw receive FDA 510(k) clearance?

MectaScrew PEEK Interference Screw received FDA 510(k) clearance on 2019-06-04, under 510(k) number K190892.

Who is the listed applicant for MectaScrew PEEK Interference Screw?

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

What is the FDA product code for MectaScrew PEEK Interference Screw?

The FDA product code for MectaScrew PEEK Interference Screw is 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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