FDA 510(k) Application Details - K223043

Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical

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510(K) Number K223043
Device Name Intervertebral Fusion Device With Bone Graft, Cervical
Applicant Integrity Spine
414 W Sunset Rd 205
San Antonio, TX 78209 US
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Contact Timothy Leak
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Regulation Number 888.3080

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Classification Product Code ODP
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Date Received 09/22/2022
Decision Date 03/20/2023
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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