Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1391668790
Device Listing 1391668790
Listing Summary
#
Listing key
1391668790
Premarket submission
K182461
Device
LATITUDE EV Total Elbow Arthroplasty
Applicant
Tornier, Inc.
Product code
JDB
Decision date
2018-12-27
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
292233
1649390
3000718467
TORNIER, INC.
1
Y
2026-01-01
10801 Nesbitt Avenue South Bloomington MN US 55437
292291
3004983210
3004983210
TORNIER Inc.
1
N
2026-01-01
4375 E. Park 30 Drive Columbia City IN US 46725
292290
3008337808
3008337808
Stryker Macroom
1
N
2026-01-01
Hartnetts Cross Macroom Co Cork Munster IE P12 XA50