FDA 510(k)

CITRELOCK® DUO

K-Number: K232592 · 2023-09-20

Decision Date2023-09-20

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CITRELOCK® DUO is a medical device manufactured by Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2023-09-20 under approval number K232592. 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 CITRELOCK® DUO?

CITRELOCK® DUO is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Acuitive Technologies, Inc.. The 510(k) number is K232592.

When was CITRELOCK® DUO approved by the FDA?

CITRELOCK® DUO received FDA 510(k) clearance on 2023-09-20, under approval number K232592.

What company makes CITRELOCK® DUO?

CITRELOCK® DUO is manufactured by Acuitive Technologies, Inc..

What is the FDA product code for CITRELOCK® DUO?

The FDA product code for CITRELOCK® DUO is MBI.

Other Devices by Acuitive Technologies, Inc.

K210239CITRESPLINE and CITRELOCK ACL Implants K203334The Citrefix Knotless Suture Anchor K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL K221468Citregen Tendon Interference Screw (TIS), Citrelock Tendon Fixation Device, Citrespline and Citrelock ACL Implants K240450Citrepore

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.