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
1730748902
Device Listing 1730748902
Listing Summary
#
Listing key
1730748902
Premarket submission
K250334
Device
Fusion Craniofacial Implant; Fusion Skull Implant
Applicant
Kelyniam Global, Inc.
Product code
GWO
Decision date
2025-07-25
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
207689
3009424796
3009424796
KELYNIAM GLOBAL INC.
1
N
2026-01-01
97 RIVER RD STE A COLLINSVILLE CT US 06019