DJ ORTHOPEDICS FEMORAL ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

DJ ORTHOPEDICS, LLC

The following data is part of a premarket notification filed by Dj Orthopedics, Llc with the FDA for Dj Orthopedics Femoral Anchor.

Pre-market Notification Details

Device IDK002829
510k NumberK002829
Device Name:DJ ORTHOPEDICS FEMORAL ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant DJ ORTHOPEDICS, LLC 990 PARK CENTER DRIVE, SUITE H Vista,  CA  92083
ContactJamal D Rushdy
CorrespondentJamal D Rushdy
DJ ORTHOPEDICS, LLC 990 PARK CENTER DRIVE, SUITE H Vista,  CA  92083
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-11
Decision Date2001-03-26

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