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FDA 510(k) Application Details - K193040
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K193040
Device Name
Filler, Bone Void, Calcium Compound
Applicant
SeaSpine Orthopedics Corporation
2 Goodyear
Irvine, CA 92618 US
Other 510(k) Applications for this Company
Contact
Caryn Sailor
Other 510(k) Applications for this Contact
Regulation Number
888.3045
More FDA Info for this Regulation Number
Classification Product Code
MQV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2019
Decision Date
11/30/2019
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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