FDA 510(k) Application Details - K091873

Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical

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510(K) Number K091873
Device Name Intervertebral Fusion Device With Bone Graft, Cervical
Applicant SPINEART
COINTRIN 20 ROUTE DE PRE-BOIS
CP1813
GENEVA 1215 CH
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Contact FRANCK PENNESI
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Regulation Number 888.3080

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Classification Product Code ODP
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Date Received 06/23/2009
Decision Date 09/18/2009
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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