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510(k) K051665

SYNTHES VECTRA-T SYSTEM by Synthes Spine — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2005
Date Received
June 22, 2005
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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  • K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
  • K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODS (January 5, 2011)

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