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510(k) K131035

Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM by Linvatec Corporation D/B/A Conmed Linvatec — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2013
Date Received
April 12, 2013
Clearance Type
Special
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

Other clearances by Linvatec Corporation D/B/A Conmed Linvatec

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  • K121890 — GENESYS PRESSFT SUTURE ANCHOR (August 22, 2012)
  • K112965 — NANO SUTURE ANCHOR (November 2, 2011)

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