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510(k) K080646

C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM by Biomet Spine — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
March 6, 2008
Clearance Type
Traditional
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

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  • K151483 — Biomet Spine Fusion System (July 31, 2015)
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  • 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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