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510(k) K130196

SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR by Arthrocare Corp. — Product Code MBI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 27, 2013
Date Received: January 28, 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

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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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