FDA.report

510(k) K233971

Device
Arthrex AlloSync PushLock Suture Anchor
Applicant
Arthrex, Inc.
510(k) number
K233971
Product code
MAI
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-04
Date received
2023-12-15
Regulation
888.3030
Classification name
Fastener, Fixation, Biodegradable, Soft Tissue
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Emmarie Halteman
Address
1370 Creekside Blvd. Naples FL US 34108 34108

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

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K260294SF Push-in AnchorSurgical Fusion Technologies GmbH2026-03-27
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K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation2025-10-15
K252022OSSIOfiber® Interference ScrewOSSIO , Ltd.2025-08-19
K251309OSSIOfiber® Suture AnchorOSSIO , Ltd.2025-05-27
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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
K240288SF Push- in AnchorSurgical Fusion Technologies GmbH2024-04-01