SWANSON TITANIUM CARPAL LUNATE IMPLANT

Prosthesis, Wrist, Carpal Lunate

DOW CORNING WRIGHT

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

Pre-market Notification Details

Device IDK864491
510k NumberK864491
Device Name:SWANSON TITANIUM CARPAL LUNATE IMPLANT
ClassificationProsthesis, Wrist, Carpal Lunate
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 CodeKWN  
CFR Regulation Number888.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-13
Decision Date1987-04-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420132802 K864491 000
00840420129123 K864491 000
00840420129116 K864491 000
00840420129109 K864491 000
00840420129093 K864491 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.