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510(k) K831005

Device
WIRE & STEINMAN PINS
Applicant
KIRSCHNER MEDICAL CORP.
510(k) number
K831005
Product code
HTY  
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-18
Date received
1983-03-30
Regulation
888.3040
Classification name
Pin, Fixation, Smooth
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
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

Legacy Summary#

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FDA Review#

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