FDA.reportPublic FDA data

510(k) K202806

Device
Fix2Lock (Biocomposite Medial, Biocomposite Lateral, Biocombi Self Punching)
Applicant
OSTEONIC Co., Ltd.
510(k) number
K202806
Product code
MBI  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-17
Date received
2020-09-23
Regulation
888.3040
Classification name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Da Kyung Ham
Address
39 Digital-Ro 29-Gil Guro-Gu KR 08381 08381

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.2026-09-17
K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.2026-09-02
K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-09-02
K262677Iconix Knotless TRiverpoint Medical2026-08-27
K262047Grappler Suture Anchor SystemParagon 28, Inc.2026-08-03
K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy2026-07-30
K261770Suture Button Repair SystemSkeletal Dynamics, Inc.2026-07-29
K261632Thunderbolt SystemResponsive Arthroscopy, Inc.2026-07-20
K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.2026-07-09
K260018Arthrex FiberButtonArthrex, Inc.2026-06-26
K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.2026-05-27
K261363Y-Knotless™ Flex AnchorsCONMED Corporation2026-05-13
K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.2026-05-06
K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-05-01
K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical2026-04-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases