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510(k) K110781

5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP by Arthrocare Corp. — Product Code MBI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 27, 2011
Date Received: March 21, 2011
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

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K111399 — SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURA (July 20, 2011)
K111397 — TITAN TI SUTURE ANCHOR SYSTEM (July 12, 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)
K100479 — PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE (September 21, 2010)

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