FDA.reportPublic FDA data

510(k) K231272

Device
OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail
Applicant
OSSIO , Ltd.
510(k) number
K231272
Product code
HTY
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-01
Date received
2023-05-02
Regulation
888.3040
Classification name
Pin, Fixation, Smooth
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Taly Lindner
Address
8 Hatochen St. Caesarea IL 3079861 3079861

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HTY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
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