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510(k) K093943

BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM by Smith & Nephew Inc., Endoscopy Div. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2010
Date Received
December 22, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K073551 — SMITH & NEPHEW INSTRUMENT TRAYS (May 21, 2008)
  • K080358 — PLLA, HA SCREW (April 23, 2008)
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