FDA.report

510(k) K251309

Device
OSSIOfiber® Suture Anchor
Applicant
OSSIO , Ltd.
510(k) number
K251309
Product code
MAI
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-27
Date received
2025-04-28
Regulation
888.3030
Classification name
Fastener, Fixation, Biodegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Taly Lindner
Address
8 Hatochen St. Caesarea IL 3079861 3079861

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MAI

510(k)DeviceApplicantDecision date
K260294SF Push-in AnchorSurgical Fusion Technologies GmbH2026-03-27
K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.2026-02-24
K251680Biosteon® ScrewBiocomposites, Ltd.2026-02-17
K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation2025-10-15
K252022OSSIOfiber® Interference ScrewOSSIO , Ltd.2025-08-19
K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy2025-05-23
K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy2025-05-21
K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO , Ltd.2025-04-03
K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.2025-03-14
K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek2025-02-05
K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.2024-12-03
K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek2024-09-11
K241912BIOCHARGENanofiber Solutions, LLC2024-07-29
K233971Arthrex AlloSync PushLock Suture AnchorArthrex, Inc.2024-06-04
K240288SF Push- in AnchorSurgical Fusion Technologies GmbH2024-04-01