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510(k) K190565

Cervical Plate by Eisertech, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2019
Date Received
March 5, 2019
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

Other clearances by Eisertech, LLC

  • K192768 — Temporary Fixation Pins (December 26, 2019)
  • K140348 — INTERBODY CAGE (April 23, 2015)
  • K142576 — Spinal System (February 26, 2015)
  • K122444 — CERVICAL CAGE (August 30, 2012)
  • K113170 — CERVICAL PLATE (April 6, 2012)
  • K113478 — PLIF CAGE (March 5, 2012)
  • K110915 — CERVICAL CAGE (July 22, 2011)

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