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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Internal Hinged Elbow Fixator
510(k) Number K231447
Device Name Double Internal Joint Stabilizer- Elbow
Applicant
Skeletal Dynamics, Inc.
7300 N Kendall Dr.
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez Rojas
Correspondent
Skeletal Dynamics, Inc.
7300 N Kendall Dr.
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez Rojas
Regulation Number888.3030
Classification Product Code
OZI  
Subsequent Product Code
LXT  
Date Received05/18/2023
Decision Date 12/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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