5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for 5.5mm Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction Tool.

Pre-market Notification Details

Device IDK110164
510k NumberK110164
Device Name:5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale,  CA  94085 -3523
ContactValerie Defiesta-ng
CorrespondentValerie Defiesta-ng
ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale,  CA  94085 -3523
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-19
Decision Date2011-02-07
Summary:summary

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