Fixone All Suture Anchor
K-Number: K222423 · 2023-03-23
ApplicantAju Pharm Co., Ltd.
Decision Date2023-03-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fixone All Suture Anchor is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under approval number K222423. 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 Fixone All Suture Anchor?
Fixone All Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K222423.
When was Fixone All Suture Anchor approved by the FDA?
Fixone All Suture Anchor received FDA 510(k) clearance on 2023-03-23, under approval number K222423.
What company makes Fixone All Suture Anchor?
Fixone All Suture Anchor is manufactured by Aju Pharm Co., Ltd..
What is the FDA product code for Fixone All Suture Anchor?
The FDA product code for Fixone All Suture Anchor is MBI.
Other Devices by Aju Pharm Co., Ltd.
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.