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
1801376057
Device Listing 1801376057
Listing Summary
#
Listing key
1801376057
Premarket submission
K153215
Device
SmartBase for Arthrex Glenoid IRIS
Applicant
Custom Orthopaedic Solutions, Inc.
Product code
KWS
Decision date
2016-02-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
1476
1220246
1220246
ARTHREX, INC.
1
N
2026-01-01
1370 Creekside Blvd Naples FL US 34108
159366
3010331645
3010331645
Arthrex, Inc.
1
N
2026-01-01
6875 Arthrex Commerce Drive Ave Maria FL US 34142
233362
3015231789
3015231789
Arthrex Manufacturing Inc.
1
N
2026-01-01
130 Arthrex Drive Pendleton SC US 29670