MODIFICATION TO 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 Modification To Classic Great Toe Implant.

Pre-market Notification Details

Device IDK023562
510k NumberK023562
Device Name:MODIFICATION TO 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 Received2002-10-23
Decision Date2002-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780257653 K023562 000
00885556834268 K023562 000
00885556834282 K023562 000
00885556834305 K023562 000
00885556834329 K023562 000
10381780257479 K023562 000
10381780257615 K023562 000
10381780257622 K023562 000
10381780257639 K023562 000
10381780257646 K023562 000
00885556834244 K023562 000

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