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

Wrench, 7mm - 00810054091615 Catalog Number :

Device Description : Wrench, 7mm

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Cutting Guide, 2mm - 00810054091622 Catalog Number :

Device Description : Cutting Guide, 2mm

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Cutting Guide, 3mm - 00810054091639 Catalog Number :

Device Description : Cutting Guide, 3mm

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Cutting Guide, 4mm - 00810054091646 Catalog Number :

Device Description : Cutting Guide, 4mm

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Cutting Guide, 5mm - 00810054091653 Catalog Number :

Device Description : Cutting Guide, 5mm

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Cutting Guide, 6mm - 00810054091660 Catalog Number :

Device Description : Cutting Guide, 6mm

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Cutting Guide Screw - 00810054091677 Catalog Number :

Device Description : Cutting Guide Screw

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Saw Blade Spacer, Long - 00810054091684 Catalog Number :

Device Description : Saw Blade Spacer, Long

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Saw Blade Spacer, Short - 00810054091691 Catalog Number :

Device Description : Saw Blade Spacer, Short

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Compression Sled Assembly - 00810054091707 Catalog Number :

Device Description : Compression Sled Assembly

Device Class : 2

Duns Number: 043505370

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

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