Flower Suture Anchor Set

Fastener, Fixation, Nondegradable, Soft Tissue

Flower Orthopedics Corporation

The following data is part of a premarket notification filed by Flower Orthopedics Corporation with the FDA for Flower Suture Anchor Set.

Pre-market Notification Details

Device IDK192949
510k NumberK192949
Device Name:Flower Suture Anchor Set
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Flower Orthopedics Corporation 100 Witmer Rd. Suite 280 Horsham,  PA  19044
ContactJessica Huang
CorrespondentAmanda Pentecost
Hogan Lovells US LLP 100 Witmer Rd. Suite 280 Horsham,  PA  19044
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-18
Decision Date2020-10-07

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