FDA 510(k) Application Details - K150455

Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical

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510(K) Number K150455
Device Name Intervertebral Fusion Device With Bone Graft, Cervical
Applicant RHAUSLER, INC.
837 INDUSTRIAL ROAD
UNIT E
SAN CARLOS, CA 94070 US
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Contact TERRY JOHNSTON
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Regulation Number 888.3080

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Classification Product Code ODP
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Date Received 02/20/2015
Decision Date 11/19/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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