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510(k) K210182

PANAMA™ Anterior Cervical Plate (ACP) System by Flospine — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2021
Date Received
January 25, 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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  • K141850 — FLOSPINE PEDICLE SCREW SYSTEM (October 27, 2014)

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