ROG KNOTLESS SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

ROG SPORTS MEDICINE, INC.

The following data is part of a premarket notification filed by Rog Sports Medicine, Inc. with the FDA for Rog Knotless Suture Anchor.

Pre-market Notification Details

Device IDK110230
510k NumberK110230
Device Name:ROG KNOTLESS SUTURE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ROG SPORTS MEDICINE, INC. 80 SHELTON TECHNOLOGY CENTER Shelton,  CT  06484
ContactCurtis Raymond
CorrespondentCurtis Raymond
ROG SPORTS MEDICINE, INC. 80 SHELTON TECHNOLOGY CENTER Shelton,  CT  06484
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-26
Decision Date2011-05-19
Summary:summary

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