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510(k) K122211

SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS by Synthes Spine — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2012
Date Received
July 25, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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  • K111358 — SYNTHES USS (November 18, 2011)
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  • K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODS (January 5, 2011)
  • K093762 — SYNTHES ZERO-P (December 20, 2010)

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