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FDA 510(k) Application Details - K161642
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K161642
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
PROVIDENCE MEDICAL TECHNOLOGY, INC
1331 N. CALIFORNIA BLVD., SUITE 320
WALNUT CREEK, CA 94596 US
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Contact
Margaret Wong
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
06/14/2016
Decision Date
10/07/2016
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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