NEXA BONE SCREW SYSTEM

Screw, Fixation, Bone

NEXA ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexa Bone Screw System.

Pre-market Notification Details

Device IDK053394
510k NumberK053394
Device Name:NEXA BONE SCREW SYSTEM
ClassificationScrew, Fixation, Bone
Applicant NEXA ORTHOPEDICS, INC. 10675 SORRENTO VALLEY ROAD SUITE 100 San Diego,  CA  92121
ContactLouise M Focht
CorrespondentLouise M Focht
NEXA ORTHOPEDICS, INC. 10675 SORRENTO VALLEY ROAD SUITE 100 San Diego,  CA  92121
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-06
Decision Date2005-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889797099332 K053394 000
00889797099325 K053394 000
00889797099318 K053394 000
00889797099301 K053394 000
00889797099295 K053394 000
00889797099288 K053394 000

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