FDA.reportPublic FDA data

510(k) K211290

Device
Cannulated Fasteners and Nuts
Applicant
OsteoCentric Technologies
510(k) number
K211290
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-03
Date received
2021-04-28
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Todd Evans
Address
75 W. 300 N. Suite 150 Logan UT US 84321 84321

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HWC#

510(k), Device, Applicant table
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K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31
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K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27