NEXFIX COMPRESSION STAPLE

Staple, Fixation, Bone

NEXA ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexfix Compression Staple.

Pre-market Notification Details

Device IDK070688
510k NumberK070688
Device Name:NEXFIX COMPRESSION STAPLE
ClassificationStaple, Fixation, Bone
Applicant NEXA ORTHOPEDICS, INC. 11035 ROSELLE STREET San Diego,  CA  92121
ContactLouise M Focht
CorrespondentLouise M Focht
NEXA ORTHOPEDICS, INC. 11035 ROSELLE STREET San Diego,  CA  92121
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-12
Decision Date2007-05-18
Summary:summary

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