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510(k) K101448

OPUS SPEEDSCREW SYSTEM by Arthrocare Corp. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2010
Date Received
May 24, 2010
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 Arthrocare Corp.

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  • K130196 — SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR (February 27, 2013)
  • K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURA (July 20, 2011)
  • K111397 — TITAN TI SUTURE ANCHOR SYSTEM (July 12, 2011)
  • K110781 — 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTR (May 27, 2011)
  • K110183 — ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (February 16, 2011)
  • K110164 — 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL (February 7, 2011)
  • K101437 — SPEEDFIX SUTURE SYSTEM (October 29, 2010)
  • K102262 — ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (October 21, 2010)

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