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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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-06-04 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K190892.

When was MectaScrew PEEK Interference Screw approved by the FDA?

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

What company makes MectaScrew PEEK Interference Screw?

MectaScrew PEEK Interference Screw is manufactured by Medacta International S.A..

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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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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