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FDA 510(k) Application Details - K190136
Device Classification Name
Prosthesis, Toe, Constrained, Polymer
More FDA Info for this Device
510(K) Number
K190136
Device Name
Prosthesis, Toe, Constrained, Polymer
Applicant
Fusion Orthopedics, LLC
4135 S. Power Rd., Suite 110
Mesa, AZ 85212 US
Other 510(k) Applications for this Company
Contact
Eli Jacobson
Other 510(k) Applications for this Contact
Regulation Number
888.3720
More FDA Info for this Regulation Number
Classification Product Code
KWH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2019
Decision Date
10/21/2019
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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