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
1219564302
Device Listing 1219564302
Listing Summary
#
Listing key
1219564302
Premarket submission
K240528
Device
b-ONE® Total Hip System
Applicant
B-One Ortho, Corp.
Product code
LZO
Decision date
2024-11-15
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
226371
3015259876
3015259876
B-ONE ORTHO, CORP.
1
Y
2026-01-01
3 Wing Drive Suite #259 Cedar Knolls NJ US 07927
346205
3042508254
3042508254
b-ONE Ortho Corp.
1
Y
2026-01-01
159 Dwight Pl Fairfield NJ US 07004