FDA.report

510(k) K253886

Device
Grappler Suture Anchor PCFD Tether System
Applicant
Paragon 28, Inc.
510(k) number
K253886
Product code
MBI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-17
Date received
2025-12-04
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Edward Wells-Spicer
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code MBI

510(k)DeviceApplicantDecision date
K261363Y-Knotless™ Flex AnchorsCONMED Corporation2026-05-13
K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.2026-05-06
K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC2026-05-01
K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical2026-04-21
K260561Arthrex FiberTak Suture AnchorArthrex, Inc.2026-03-20
K254176SINEFIXBAAT Medical Products B.V.2026-03-16
K251750Trax EX AnchorTrax Surgical, Inc.2026-03-12
K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC2026-03-11
K260405FiberTape ButtonArthrex, Inc.2026-03-09
K253538TeKBrace Knotless AnchorTheramicro2026-03-06
K254306Aevumed FENIX Suture AnchorAevumed, Inc.2026-03-04
K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.2026-03-02
K253695LigaMendRiverpoint Medical, LLC2026-02-27
K253763Y-Knotless™ Flex AnchorsConmed Corporation2026-01-29
K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.2026-01-28