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510(k) K122989

BIOMET LATERAL SPACER SYSTEM by Biomet Spine (Aka Ebi, LLC) — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2012
Date Received
September 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Biomet Spine (Aka Ebi, LLC)

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  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (February 25, 2013)
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  • 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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