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510(k) K071667

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2007
Date Received
June 19, 2007
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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  • K120928 — SYNTHES MATRIX SYSTEM (May 18, 2012)
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  • K113149 — SYNTHES USS CONNECTORS (February 1, 2012)
  • K113044 — SYNTHES MIRS (December 21, 2011)
  • K111358 — SYNTHES USS (November 18, 2011)
  • 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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