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510(k) K110915

CERVICAL CAGE by Eisertech, LLC — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2011
Date Received
April 1, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Eisertech, LLC

  • K192768 — Temporary Fixation Pins (December 26, 2019)
  • K190565 — Cervical Plate (May 31, 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)

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