CLASSIC GREAT TOE IMPLANT

Prosthesis, Toe, Constrained, Polymer

NEXA ORTHOPEDICS, INC.

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

Pre-market Notification Details

Device IDK023086
510k NumberK023086
Device Name:CLASSIC GREAT TOE IMPLANT
ClassificationProsthesis, Toe, Constrained, 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 CodeKWH  
CFR Regulation Number888.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-17
Decision Date2002-10-04
Summary:summary

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