GEMINUS FOSSA SPECIFIC PLATE SYSTEM

Plate, Fixation, Bone

SKELETAL DYNAMICS, LLC

The following data is part of a premarket notification filed by Skeletal Dynamics, Llc with the FDA for Geminus Fossa Specific Plate System.

Pre-market Notification Details

Device IDK122737
510k NumberK122737
Device Name:GEMINUS FOSSA SPECIFIC PLATE SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami,  FL  33176
ContactAna M Escagedo
CorrespondentAna M Escagedo
SKELETAL DYNAMICS, LLC 8905 SW 87 AVENUE, SUITE 201 Miami,  FL  33176
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-06
Decision Date2012-10-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.