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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade Name4WEB Medical Talar Replacement Device
Classification Nameprosthesis, total talus replacement, metal
Generic Nameprosthesis, total talus replacement, metal
Applicant
Stryker
1023 cherry road
memphis, TN 38117
HDE NumberH240001
Date Received01/16/2024
Decision Date12/27/2024
Product Code
QNN[ Registered Establishments with QNN ]
Docket Number 25M-0049
Notice Date 01/10/2025
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The 4web medical talar replacement device is indicated for avascular necrosis (avn) of the talus requiring replacement. The anatomical landmarks necessary for the design and creation of the 4web medical talar replacement device must be present and identifiable on ct scan.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 
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