Fixone Meniscal Repair
K-Number: K233601 · 2024-08-02
ApplicantAju Pharm Co., Ltd.
Decision Date2024-08-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fixone Meniscal Repair is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under approval number K233601. 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 Meniscal Repair?
Fixone Meniscal Repair is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K233601.
When was Fixone Meniscal Repair approved by the FDA?
Fixone Meniscal Repair received FDA 510(k) clearance on 2024-08-02, under approval number K233601.
What company makes Fixone Meniscal Repair?
Fixone Meniscal Repair is manufactured by Aju Pharm Co., Ltd..
What is the FDA product code for Fixone Meniscal Repair?
The FDA product code for Fixone Meniscal Repair is MBI.
Related Clinical Trials
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.