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
1195912347
Device Listing 1195912347
Listing Summary
#
Listing key
1195912347
Premarket submission
K111041
Device
MINI VARIABLE SYSTEM
Applicant
Orthohelix Surgical Designs, Inc.
Product code
HRS
Decision date
2011-06-06
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
75317
1649390
3000718467
TORNIER, INC.
1
Y
2020-04-25
10801 Nesbitt Avenue South Bloomington MN US 55437
75320
3004983210
3004983210
TORNIER Inc.
1
N
2020-04-25
4375 E. Park 30 Drive Columbia City IN US 46725