BoneCam Suture Anchors

Fastener, Fixation, Nondegradable, Soft Tissue

VALERIS MEDICAL

The following data is part of a premarket notification filed by Valeris Medical with the FDA for Bonecam Suture Anchors.

Pre-market Notification Details

Device IDK152255
510k NumberK152255
Device Name:BoneCam Suture Anchors
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant VALERIS MEDICAL 200 COBB PKW N, BLDG 200, STE 210 Marietta,  GA  30062
ContactDaniel Lanois
CorrespondentCheryl Wagoner
WAGONER CONSULTING LLC PO BOX 15729 Wilmington,  NC  28408
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-10
Decision Date2015-11-16
Summary:summary

NIH GUDID Devices

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