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510(k) K010551

EBI DYNAFIX VS OSTEOTOMY SYSTEM by Ebi, L.P. — Product Code NDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2001
Date Received
February 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone, Non-Spinal, Metallic
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Ebi, L.P.

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  • 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)

Other clearances for product code NDF

  • K051642 — FR.O.H. CALCANEUS REPAIR SYSTEM (August 22, 2005)
  • K021749 — EBI DYNAFIX VS OSTEOTOMY SYSTEM (August 12, 2002)