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FDA 510(k) Application Details - K163543
Device Classification Name
More FDA Info for this Device
510(K) Number
K163543
Device Name
Biomet Fusion System
Applicant
Zimmer Biomet Spine Inc.
310 Interlocken Parkway Suite 120
Broomfield, CO 80021 US
Other 510(k) Applications for this Company
Contact
Megan Fessenden
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
OVD
Other 510(k) Applications for this Device
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Date Received
12/16/2016
Decision Date
02/28/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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