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FDA 510(k) Application Details - K161280
Device Classification Name
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510(K) Number
K161280
Device Name
Cervical Stand Alone System
Applicant
Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 US
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Contact
Natalia Volosen
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Regulation Number
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Classification Product Code
OVE
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Date Received
05/06/2016
Decision Date
06/17/2016
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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