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
1014704846
Device Listing 1014704846
Listing Summary
#
Listing key
1014704846
Premarket submission
K113071
Device
SYNTHECEL DURA REPLACEMENT DEVICES
Applicant
Synthes
Product code
GXQ
Decision date
2012-01-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
7737
1719045
1719045
SYNTHES (USA), LLC
1
Y
2020-04-25
1051 Synthes Ave MONUMENT CO US 80132
124245
3008812560
3008812560
Synthes (USA) Products LLC
1
Y
2026-01-01
1301 Goshen Pkwy West Chester PA US 19380
158190
3010197348
3010197348
Synthes USA
1
N
2020-04-25
1210 Ward Ave West Chester PA US 19380
334834
3034676720
3034676720
DePuy Synthes Sales
1
N
2026-01-01
75 Fruit St Bridgewater MA US 02324