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510(k) K192768

Temporary Fixation Pins by Eisertech, LLC — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2019
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Eisertech, LLC

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  • 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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