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510(k) K103393

POLARIS SPINAL SYSTEM by Biomet Spine — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2011
Date Received
November 19, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Biomet Spine

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  • K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge (August 12, 2015)
  • K151483 — Biomet Spine Fusion System (July 31, 2015)
  • K151224 — Lineum OCT Spine System (June 30, 2015)
  • K142634 — Biomet Spine Fusion System (March 12, 2015)
  • K141791 — BIOMET FUSION SYSTEM (October 9, 2014)
  • K141804 — POLARIS SPINAL SYSTEM - HA COATED (September 25, 2014)
  • K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS (June 15, 2012)

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