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510(k) K210325

APOLLO Anterior Cervical Plate (ACP) System by Aurora Spine, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2021
Date Received
February 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K141317 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 17, 2014)
  • K140715 — ZIP MIS INTERSPINOUS FUSION SYSTEM (April 17, 2014)
  • K133967 — INTERBODY CAGE SYSTEM (January 31, 2014)
  • K133091 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 27, 2013)

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