OPUS SPEEDSCREW SYSTEM

Screw, Fixation, Bone

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Speedscrew System.

Pre-market Notification Details

Device IDK100457
510k NumberK100457
Device Name:OPUS SPEEDSCREW SYSTEM
ClassificationScrew, Fixation, Bone
Applicant ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine,  CA  92618
ContactLaura N Kasperowicz
CorrespondentLaura N Kasperowicz
ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine,  CA  92618
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-17
Decision Date2010-03-19
Summary:summary

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