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

TONG, SKULL FOR TRACTION (HAX) (7) FIXATION ACCESSORY (LYT) (2) Kit, surgical instrument, disposable (KDD) (1)

Premarket Exempt

No Yes

Clear

Halo Systems - 05690977164116 Catalog Number : 505400C

Device Description : HALO RINGS MDIUM

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977164130 Catalog Number : 505500C

Device Description : HALO RINGS LG

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977165335 Catalog Number : 540C

Device Description : RESOLVE HALO COMP TRAY

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977192348 Catalog Number : 540V2

Device Description : STERILE V2 COMPONENT TRAY

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977192577 Catalog Number : 517DS

Device Description : Skull Pin 3in CT Sterl 4 PK

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : LYT

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977193123 Catalog Number : JT-400

Device Description : J TONG COMPONENT TRAY

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977193192 Catalog Number : 515C4

Device Description : RESOLVE TRACTION HOOP

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977194090 Catalog Number : 516CS

Device Description : Skull Pin 2-1/4in CT Sterl 1PK

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : LYT

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977196636 Catalog Number : 538

Device Description : HALO APPLICATION TRAY

Device Class : 1

Duns Number: 139280028

Premarket Exempt : No

Product Code : KDD

Prescription Use : Yes

Device Count : 1

Halo Systems - 05690977197275 Catalog Number : JT-100

Device Description : J TONG ASSEMBLY MED/LGE

Device Class : 2

Duns Number: 139280028

Premarket Exempt : No

Product Code : HAX

Prescription Use : Yes

Device Count : 1

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