CROSSCHECK PLATING SYSTEM

Plate, Fixation, Bone

SOLANA SURGICAL, LLC

The following data is part of a premarket notification filed by Solana Surgical, Llc with the FDA for Crosscheck Plating System.

Pre-market Notification Details

Device IDK132594
510k NumberK132594
Device Name:CROSSCHECK PLATING SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SOLANA SURGICAL, LLC 6363 POPLAR AVENUE SUITE 312 Memphis,  TN  38119
ContactJoe Clift
CorrespondentJoe Clift
SOLANA SURGICAL, LLC 6363 POPLAR AVENUE SUITE 312 Memphis,  TN  38119
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-19
Decision Date2013-12-13
Summary:summary

NIH GUDID Devices

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