Product code HTY

Device name
Pin, Fixation, Smooth
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3040
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Source
FDA openFDA device classification dataset

Related 510(k) Records

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K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions2025-12-29
K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.2025-09-19
K250315RONAVIS – FX (FX-001)AIRS, Inc.2025-08-01
K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.2025-06-24
K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies2025-06-11
K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc.2024-05-22
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd.2023-12-01
K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation2023-09-14
K230750OSSIOfiber® Cannulated Trimmable Fixation NailOSSIO , Ltd.2023-09-13
K231905Electro-Spec Steri-CapsElectro-Spec, Inc.2023-08-14
K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLC2023-07-06
K221283Hammertoe Truss System (HTS)4Web Medical, Inc.2022-09-06
K220906SECURE-LOCKXiros, Ltd.2022-07-22
K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific Instruments2022-02-17
K211789restor3d Pin ImplantsRestor3D2022-01-04
K211439Small Bone Nailing SystemSkeletal Dynamics, Inc.2021-09-30
K203698CoLink Sfx Implant SystemIn2bones USA, LLC2021-05-04
K203475LimaCorporate Kirschner WireLima Corporate S.P.A.2021-02-05
K201838PediFlex Flexible Nail SystemOrthoPediatrics Corp.2021-01-29
K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated DesignOSSIO , Ltd.2021-01-06
K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.2020-11-17
K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO , Ltd.2020-10-16
K201715Smart Toe II, X FuseStryker GmbH2020-08-05
K200068Arthrex DynaNite K-WireArthrex, Inc.2020-06-29
K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO , Ltd.2020-03-06
K190926Hammertoe Truss System (HTS)4Web, Inc.2019-07-23
K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.2019-05-03
K183228HammerToe Compression SystemParagon 28, Inc.2019-01-25
K181180OSSIO™ Pin Product FamilyOSSIO , Ltd.2019-01-10
K180087A.M. Surgical Intramedullary Fixation DeviceA.M. Surgical, Inc.2018-05-18

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