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
1430423823
Device Listing 1430423823
Listing Summary
#
Listing key
1430423823
Premarket submission
K102323
Device
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Theken Spine, LLC
Product code
OVE
Decision date
2010-12-16
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
66485
3005641619
3005641619
PACIFIC INSTRUMENTS INC.
1
Y
2026-01-01
438 Hobron Lane Suite 204 Honolulu HI US 96815