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510(k) K140710

BIOMET GRAFT DELIVERY SYRINGES by Biomet Spine (Aka Ebi, LLC) — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2014
Date Received
March 21, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Biomet Spine (Aka Ebi, LLC)

  • K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEM (November 5, 2014)
  • K132373 — BIOMET ACCESS SYSTEM (March 27, 2014)
  • K133746 — POLARIS SPINAL SYSTEM (March 12, 2014)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (February 25, 2013)
  • K123451 — POLARIS SPINAL SYSTEM - BALLISTA II RODS (December 3, 2012)
  • K122989 — BIOMET LATERAL SPACER SYSTEM (October 24, 2012)
  • K122378 — NEXTGEN ALTIUS OCT SYSTEM (September 20, 2012)
  • K113593 — NEXTGEN ALTIUS OCT SYSTEM (April 17, 2012)
  • K110650 — ZYSTON ARC INTERBODY SPACER (June 30, 2011)

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