N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHROCARE CORPORATION

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for N8tive Acl Anatomic Reconstruction System, N8tive Acl Femoral Implant, N8tive Acl Tibial Implant, Various Class I Ancill.

Pre-market Notification Details

Device IDK133606
510k NumberK133606
Device Name:N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin,  TX  78735
ContactMitchell Dhority
CorrespondentMitchell Dhority
ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin,  TX  78735
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-25
Decision Date2014-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470011074 K133606 000
00817470011005 K133606 000
00817470010992 K133606 000

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