OSSUR AMERICAS, INC.

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 - 05690967514341 Catalog Number : PRX00421

Device Description : KIT POWERSUPPLY PROPRIO/RHEO

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967529772 Catalog Number : PKN120007

Device Description : POWER KNEE G2 KIT NA

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Rheo Knee - 05690967529864 Catalog Number : RKN12100

Device Description : RHEO KNEE LOANER

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967538804 Catalog Number : PKN12100

Device Description : POWER KNEE II LOANER

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967556815 Catalog Number : PK220007

Device Description : POWER KNEE BATTERY CHARGER NA

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967556822 Catalog Number : PK230010

Device Description : POWER KNEE BATTERY UNIT

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Power Knee - 05690967566029 Catalog Number : PKN123007

Device Description : POWER KNEE G2 KIT NA EUP

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Rheo Knee - 05690967566227 Catalog Number : RKNLPCWB1

Device Description : RHEOLOGIC WORKBENCH PC 4.0.1

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : No

Device Count : 1

Symbionic Leg - 05690967567583 Catalog Number : SBL12112

Device Description : SYMBIONIC LEG LOANER 22-24

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

Symbionic Leg - 05690967567590 Catalog Number : SBL12102

Device Description : SYMBIONIC LEG LOANER 25-30

Device Class : 2

Duns Number: 139280028

Premarket Exempt : Yes

Product Code : ISW

Prescription Use : Yes

Device Count : 1

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