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510(k) K042778

BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE by Linvatec Corp. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2004
Date Received
October 6, 2004
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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  • K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL (February 25, 2009)
  • K060198 — MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND (May 11, 2006)
  • K060270 — MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL (April 10, 2006)
  • K060260 — MICROPOWER HAND PIECE HIGH SPEED DRILL (April 10, 2006)
  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K050497 — BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET (March 25, 2005)

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