ClearanceBrief
Company ยท KR

Aju Pharm Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2024. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (0 in 12 months)
8recalls (8 in 12 months)
8recalls that name a 510(k)

Product codes

CodeDeviceRecords
MAIFastener, Fixation, Biodegradable, Soft Tissue13
MBIFastener, Fixation, Nondegradable, Soft Tissue3
HRXArthroscope1
HWCScrew, Fixation, Bone1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 2, 2024K233601Fixone Meniscal Repair
Aju Pharm Co., Ltd., KR
MBI
Jun 9, 2023K230892Fixone Biocomposite Anchor
Aju Pharm Co., Ltd., KR
MAI
Mar 23, 2023K222423Fixone All Suture Anchor
Aju Pharm Co., Ltd., KR
MBI
Dec 25, 2021K203523Fixone hybrid knotless anchor
Aju Pharm Co., Ltd., KR
MAI
Jan 5, 2021K193497Fixone Biocomposite Interference Screw
Aju Pharm Co., Ltd., KR
HWC
Dec 15, 2020K192709Fixone All Suture Anchor
Aju Pharm Co., Ltd., KR
MBI
Mar 11, 2020K192484Fixone Biocomposite Anchor
Aju Pharm Co., Ltd., KR
MAI
Mar 3, 2020K192032Fixone Biocomposite Small Anchor
Aju Pharm Co., Ltd., KR
MAI
Aug 24, 2017K171299Fixone Biocomposite Anchor
Aju Pharm Co., Ltd., KR
MAI
Mar 16, 2017K162070JOINIX CANNULAR SYSTEM
Aju Pharm Co., Ltd., KR
HRX

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 26, 2026Aju Pharm Co., Ltd.
AlternatiV+ Screw-In Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
AlternatiV+ Max Knotless Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Push-In Suture Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Knotless Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Dual Thread Screw-In Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Genesis Screw-In Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Fixone Biocomposite Anchor
Open, Classified		 MAIK193497
K203523 +3
Jan 26, 2026Aju Pharm Co., Ltd.
Fixone Hybrid Anchor
Open, Classified		 MAIK193497
K203523 +3
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