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510(k) K230094

Device
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
Applicant
Responsive Arthroscopy, LLC
510(k) number
K230094
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-25
Date received
2023-01-12
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
Garrett Ahlborg
Address
701 N. 3rd St. Suite 208 Minneapolis MN US 55401 55401

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
K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINITSmith & Nephew, Inc.2026-10-23
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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
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