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510(k) K221792

Device
Acute QC Strut And Components
Applicant
Smith & Nephew, Inc.
510(k) number
K221792
Product code
OSN  
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-25
Date received
2022-06-21
Regulation
888.3030
Classification name
Software For Diagnosis/treatment
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Amanda Lammey
Address
7135 Goodlett Farms Pkwy. Cordova TN US 38016 38016

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OSN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253764ENOS Software Guided External Fixation SystemDisior, Ltd.2026-02-26
K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC2018-08-13
K140550ORTHOHUB EXTERNAL FIXATOR SOFTWAREOrthohub, Inc.2014-08-25

Legacy Summary#

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FDA Review#

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