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510(k) K061016

EBI ESL PEEK-OPTIMA SPINE SYSTEM by Ebi, L.P. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2006
Date Received
April 13, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Ebi, L.P.

  • K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (June 23, 2010)
  • K100220 — POLARIS SPINAL SYSTEM (May 17, 2010)
  • 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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