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510(k) K220901

Device
S-Core Implant System
Applicant
Subchondral Solutions, Inc.
510(k) number
K220901
Product code
MBI  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-29
Date received
2022-03-28
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
Michael Kolber
Address
7146 Edinger Ave. Suite A Huntington Beach CA US 92647 92647

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
K263477Arthrex FiberButtonArthrex, Inc.2026-10-27
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
K263352TeKBrace Knotless AnchorTheraMicro2026-10-21
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

Legacy Summary#

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FDA Review#

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