AVANTI ORTHOPAEDICS LLC

Address:1245 Hollow Road,Penn Valley,PA,19072,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

Plate, Fixation, Bone (HRS) (10) Screw, Fixation, Bone (HWC) (10)

Premarket Exempt

Clear

Sled (CS00 Sub-Component) - 00810054091714 Catalog Number :

Device Description : Sled (CS00 Sub-Component)

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Block (CS00 Sub-Component) - 00810054091721 Catalog Number :

Device Description : Block (CS00 Sub-Component)

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Block Screw (CS00 Sub-Component) - 00810054091738 Catalog Number :

Device Description : Block Screw (CS00 Sub-Component)

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Ulnar Shortening Caddy - 00810054091745 Catalog Number :

Device Description : Ulnar Shortening Caddy

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Lid, Screw Side (USCD Sub-Component) - 00810054091752 Catalog Number :

Device Description : Lid, Screw Side (USCD Sub-Component)

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Lid, Tool Side (USCD Sub-Component) - 00810054091769 Catalog Number :

Device Description : Lid, Tool Side (USCD Sub-Component)

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, Wide, Right, 5 Hole - 00810054091776 Catalog Number :

Device Description : Volar PEEK Plate, Wide, Right, 5 Hole

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, Wide, Left, 5 Hole - 00810054091783 Catalog Number :

Device Description : Volar PEEK Plate, Wide, Left, 5 Hole

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Reduction Tool - 00810054091790 Catalog Number :

Device Description : Reduction Tool

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Bone Clamp Ulnar Shortening - 00810054091806 Catalog Number :

Device Description : Bone Clamp Ulnar Shortening

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

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