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FDA 510(k) Application Details - K211439
Device Classification Name
Pin, Fixation, Smooth
More FDA Info for this Device
510(K) Number
K211439
Device Name
Pin, Fixation, Smooth
Applicant
Skeletal Dynamics, Inc.
7300 N. Kendall Drive, Suite 400
Miami, FL 33156 US
Other 510(k) Applications for this Company
Contact
Ana M Escagedo
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HTY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/10/2021
Decision Date
09/30/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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