FDA.reportPublic FDA data

510(k) K240288

Device
SF Push- in Anchor
Applicant
Surgical Fusion Technologies GmbH
510(k) number
K240288
Product code
MAI
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-01
Date received
2024-02-01
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
No

Applicant Contact#

Contact
Joerg Mayer
Address
Wagistrasse 6 Schlieren CH 8952 8952

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260294SF Push-in AnchorSurgical Fusion Technologies GmbH2026-03-27
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K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO , Ltd.2025-04-03
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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