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
1729276841
Device Listing 1729276841
Listing Summary
#
Listing key
1729276841
Premarket submission
K171634
Device
Ortho System
Applicant
3Shape A/S
Product code
PNN
Decision date
2018-01-17
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
79324
3005940400
3005940400
David Rothkopf
1
N
2026-01-01
200 Homer Ave Ashland MA US 01721
165236
3010728558
3010728558
3shape inc
1
Y
2026-01-01
430 Mountain Avenue, Suite 205 New Providence NJ US 07974