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510(k) K060714

HI-FI ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR by Conmed Linvatec — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2006
Date Received
March 17, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES (October 19, 2009)
  • K090560 — CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS (June 29, 2009)
  • K083161 — ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) (March 27, 2009)
  • K080531 — CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY (September 5, 2008)
  • K072291 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR (July 14, 2008)
  • K080444 — CONMED LINVATEC OSPREY DRILL SYSTEM (April 2, 2008)

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