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510(k) K082187

BIOMET ANTERIOR LUMBAR PLATE by Ebi, L.P. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2008
Date Received
August 4, 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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  • K090523 — POLARIS SPINAL SYSTEM (July 1, 2009)
  • K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT (January 14, 2009)

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