SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROCARE CORPORATION

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Speedlock Hip Knotless Fixation Implant.

Pre-market Notification Details

Device IDK123240
510k NumberK123240
Device Name:SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin,  TX  78735
ContactCheryl Frederick
CorrespondentCheryl Frederick
ARTHROCARE CORPORATION 7000 W William Cannon Dr Austin,  TX  78735
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-16
Decision Date2013-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470003499 K123240 000
00817470003482 K123240 000
00817470003475 K123240 000
00817470003413 K123240 000

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