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Company-Registration
1060623059
Device Listing 1060623059
Listing Summary
#
Listing key
1060623059
Premarket submission
K160982
Device
Sphynxâ„¢
Applicant
Eden Spine, LLC
Product code
KWQ
Decision date
2016-12-22
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
163021
3010560653
3010560653
Omnia Medical
1
Y
2026-01-01
6 Canyon Rd MORGANTOWN WV US 26508