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510(k) K061441

EBI 5.5 HELICAL FLANGE SPINAL SYSTEM by Ebi, L.P. — Product Code MNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2006
Date Received
May 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spondylolisthesis Spinal Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Ebi, L.P.

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  • K093880 — PEANUT GROWTH CONTROL PLATING SYSTEM (April 16, 2010)
  • K092574 — ESL SPINAL SYSTEM (February 4, 2010)
  • K093057 — BIOMET VISION FOOTRING SYSTEM (December 1, 2009)
  • K092336 — C-THRU SPINAL SYSTEM (October 15, 2009)
  • K091381 — IBEX SPINAL SYSTEM (August 7, 2009)
  • K090203 — 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (July 30, 2009)
  • K090523 — POLARIS SPINAL SYSTEM (July 1, 2009)
  • K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT (January 14, 2009)

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  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
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  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)