SWANSON TITANIUM GREAT TOE IMPLANT

Prosthesis, Toe, Hemi-, Phalangeal

DOW CORNING WRIGHT

The following data is part of a premarket notification filed by Dow Corning Wright with the FDA for Swanson Titanium Great Toe Implant.

Pre-market Notification Details

Device IDK864492
510k NumberK864492
Device Name:SWANSON TITANIUM GREAT TOE IMPLANT
ClassificationProsthesis, Toe, Hemi-, Phalangeal
Applicant DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
ContactAnthony J Lentz
CorrespondentAnthony J Lentz
DOW CORNING WRIGHT P.O. BOX 100 Arlington,  TN  38002
Product CodeKWD  
CFR Regulation Number888.3730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-13
Decision Date1987-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420121752 K864492 000
00840420125651 K864492 000
00840420125668 K864492 000
00840420125675 K864492 000
00840420125682 K864492 000
00840420125699 K864492 000
00840420198693 K864492 000
00840420198709 K864492 000
00840420198716 K864492 000
00840420198723 K864492 000
00840420198730 K864492 000
00840420121714 K864492 000
00840420121721 K864492 000
00840420121738 K864492 000
00840420121745 K864492 000
00840420125644 K864492 000

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