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FDA 510(k) Application Details - K202666
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K202666
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Orthofix Inc.
3451 Plano Parkway
Lewisville, TX 75056 US
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Contact
Natalia Volosen
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
09/14/2020
Decision Date
10/14/2020
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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