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

Volar Fixed Angle Plate, 3 Hole, Left - 00810054090014 Catalog Number :

Device Description : Volar Fixed Angle Plate, 3 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar Fixed Angle Plate, 3 Hole, Right - 00810054090021 Catalog Number :

Device Description : Volar Fixed Angle Plate, 3 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar Fixed Angle Plate, 5 Hole, Left - 00810054090038 Catalog Number :

Device Description : Volar Fixed Angle Plate, 5 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar Fixed Angle Plate, 5 Hole, Right - 00810054090045 Catalog Number :

Device Description : Volar Fixed Angle Plate, 5 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar Fixed Plate, Wide, 5 Hole, Left - 00810054090052 Catalog Number :

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

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar Fixed Plate, Wide, 5 Hole, Right - 00810054090069 Catalog Number :

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

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 3 Hole, Left - 00810054090076 Catalog Number :

Device Description : Volar PEEK Plate, 3 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 3 Hole, Right - 00810054090083 Catalog Number :

Device Description : Volar PEEK Plate, 3 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 5 Hole, Left - 00810054090090 Catalog Number :

Device Description : Volar PEEK Plate, 5 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 5 Hole, Right - 00810054090106 Catalog Number :

Device Description : Volar PEEK Plate, 5 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

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