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
1494339725
Device Listing 1494339725
Listing Summary
#
Listing key
1494339725
Premarket submission
K162733
Device
iFuse Implant System® - iFuse-3D implant
Applicant
SI-BONE, Inc.
Product code
OUR
Decision date
2017-03-10
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
103722
3007700286
3007700286
SI-BONE, INC.
1
N
2026-01-01
471 El Camino Real, Suite 101 Santa Clara CA US 95050
302694
3021948057
3021948057
SI-BONE, INC.
1
N
2026-01-01
2380 Owen St. Santa Clara CA US 95054