Ortoway Ab

FDA Filings

This page includes the latest FDA filings for Ortoway Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011327886
FEI Number3011327886
NameOrtoway AB
Owner & OperatorOrtoway AB
Contact AddressSvaerdvaegen 21
Danderyd SE-NOTA SE-182 33 SE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSvaerdvaegen 21
Danderyd Stockholms lan [SE-01], SE-182 33 SE
Establishment TypeManufacture Medical Device



Registration Number3009596010
FEI Number3009596010
NameOrtoway LLC
Owner & OperatorOrtoway AB
Contact AddressSvaerdvaegen 21
Danderyd SE-NOTA SE-182 33 SE
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2 Walnut Grove Dr
Horsham, PA 19044 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Ortoway LLC [Ortoway AB]
OrtoWell Distractor2012-04-30
Ortoway AB
OrtoWell Distractor2012-04-30

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