OSSUR AMERICAS, INC.

Address:27051 Towne Centre Drive,Foothill Ranch,CA,92610,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL (ISW) (10)

Premarket Exempt

No Yes

Clear

Rheo Knee - 05690967600594 Catalog Number : RKN13210

Device Description : RHEO KNEE 3 W LOCK TRIAL

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Rheo Knee - 05690967600600 Catalog Number : RKN13200

Device Description : RHEO KNEE 3 TRIAL

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Symbionic Leg - 05690967600655 Catalog Number : SBL13110

Device Description : SYMBIONIC LEG 3 LOANER 25-30

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Symbionic Leg - 05690967600662 Catalog Number : SBL13111

Device Description : SYMBIONIC LEG 3 LOANER 22-24

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Symbionic Leg - 05690967600679 Catalog Number : SBL13210

Device Description : SYMBIONIC LEG 3 TRIAL 25-30

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Symbionic Leg - 05690967600686 Catalog Number : SBL13211

Device Description : SYMBIONIC LEG 3 TRIAL 22-24

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967603410 Catalog Number : PK23100

Device Description : POWER KNEE BATTERY LOANER

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967603427 Catalog Number : PK22100

Device Description : POWER KNEE BATT CHARGER LOANER

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Rheo Knee - 05690967610517 Catalog Number : RKN13140

Device Description : RHEO KNEE 3 WP Loaner

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Rheo Knee - 05690967613136 Catalog Number : RKN13130

Device Description : RHEO KNEE XC LOANER

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

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