SUBTALAR PEG IMPLANT

Prosthesis, Subtalar, Plug, Polymer

NEXA ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Subtalar Peg Implant.

Pre-market Notification Details

Device IDK033046
510k NumberK033046
Device Name:SUBTALAR PEG IMPLANT
ClassificationProsthesis, Subtalar, Plug, Polymer
Applicant NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista,  CA  92083
ContactLouise M Focht
CorrespondentLouise M Focht
NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista,  CA  92083
Product CodeMJW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2003-12-23
Summary:summary

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