OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500

Screw, Fixation, Bone

ARTHROCARE CORP.

The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Magnum Speedscrew Knotless Fixation Device, Model Om-6500.

Pre-market Notification Details

Device IDK081893
510k NumberK081893
Device Name:OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
ClassificationScrew, Fixation, Bone
Applicant ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine,  CA  92618
ContactLaura Kasperowicz
CorrespondentLaura Kasperowicz
ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine,  CA  92618
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-03
Decision Date2008-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470006414 K081893 000
00817470006407 K081893 000
00817470006391 K081893 000
00817470006384 K081893 000
00817470005196 K081893 000
00817470005172 K081893 000
00817470001242 K081893 000

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