RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

Fastener, Fixation, Nondegradable, Soft Tissue

CORE ESSENCE ORTHOPAEDICS, LLC

The following data is part of a premarket notification filed by Core Essence Orthopaedics, Llc with the FDA for Renovo Suture Anchors, Models 100-2001 Thru 100-5502x.

Pre-market Notification Details

Device IDK071520
510k NumberK071520
Device Name:RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B Yardley,  PA  19067
ContactShawn T Huxel
CorrespondentShawn T Huxel
CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B Yardley,  PA  19067
Product CodeMBI  
Subsequent Product CodeHWC
Subsequent Product CodeJDR
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-04
Decision Date2007-08-10
Summary:summary

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