Acute QC Strut And Components

Software For Diagnosis/treatment

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Acute Qc Strut And Components.

Pre-market Notification Details

Device IDK221792
510k NumberK221792
Device Name:Acute QC Strut And Components
ClassificationSoftware For Diagnosis/treatment
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactAmanda Lammey
CorrespondentAmanda Lammey
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeOSN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-21
Decision Date2022-08-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556807064 K221792 000
00885556807057 K221792 000
20885556807129 K221792 000
20885556807112 K221792 000
20885556807105 K221792 000
20885556807099 K221792 000
00885556807088 K221792 000
00885556807071 K221792 000

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