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510(k) K143688

ASFORA ANTERIOR CERVICAL PLATE SYSTEM by Medical Designs, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2015
Date Received
December 24, 2014
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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  • K042359 — SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS- (November 17, 2004)
  • K002970 — SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 (December 12, 2000)

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