PYLON INTRAMEDULLAARY NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

ALPHATEC MFG., INC.

The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Pylon Intramedullaary Nail System.

Pre-market Notification Details

Device IDK992350
510k NumberK992350
Device Name:PYLON INTRAMEDULLAARY NAIL SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert,  CA  92211 -5148
ContactJason Blain
CorrespondentJason Blain
ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert,  CA  92211 -5148
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-14
Decision Date1999-09-22
Summary:summary

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