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 PEEK Plate, 7 Hole, Left - 00810054090113 Catalog Number :

Device Description : Volar PEEK Plate, 7 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 7 Hole, Right - 00810054090120 Catalog Number :

Device Description : Volar PEEK Plate, 7 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 9 Hole, Left - 00810054090137 Catalog Number :

Device Description : Volar PEEK Plate, 9 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 9 Hole, Right - 00810054090144 Catalog Number :

Device Description : Volar PEEK Plate, 9 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 11 Hole, Left - 00810054090151 Catalog Number :

Device Description : Volar PEEK Plate, 11 Hole, Left

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Volar PEEK Plate, 11 Hole, Right - 00810054090168 Catalog Number :

Device Description : Volar PEEK Plate, 11 Hole, Right

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Ulnar Plate, 5 Hole - 00810054090175 Catalog Number :

Device Description : Ulnar Plate, 5 Hole

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Ulnar Plate, 7 Hole - 00810054090182 Catalog Number :

Device Description : Ulnar Plate, 7 Hole

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Straight Plate, 6 Hole - 00810054090199 Catalog Number :

Device Description : Straight Plate, 6 Hole

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Straight Plate, 8 Hole - 00810054090205 Catalog Number :

Device Description : Straight Plate, 8 Hole

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

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