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
1621166378
Device Listing 1621166378
Listing Summary
#
Listing key
1621166378
Premarket submission
K220357
Device
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
Applicant
Medcad
Product code
GXN
Decision date
2022-08-26
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
131085
3009196021
3009196021
VanDuzen, Inc. dba MedCAD
1
N
2026-01-01
501 S 2nd Ave Ste A1000 Dallas TX US 75226
302612
3021635140
3021635140
MedCAD
1
N
2026-01-01
3401 Technology Dr Unit 3 Plano TX US 75074