NEW ERA ORTHOPEDICS LLC

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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

Orthosis, Spinal Pedicle Fixation (MNI) (10)

Premarket Exempt

Clear

NEO Modera Pedicle Screw System - 00815730022419 Catalog Number : 3PS85-110-01

Device Description : Poly-Axial Screw, Solid Ø8.5mm x 110mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022426 Catalog Number : 3PS85-120-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 120mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022433 Catalog Number : 3PS85-30-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 30mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022440 Catalog Number : 3PS85-35-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 35mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022457 Catalog Number : 3PS85-40-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 40mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022464 Catalog Number : 3PS85-45-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 45mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022471 Catalog Number : 3PS85-50-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 50mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022488 Catalog Number : 3PS85-55-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 55mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022495 Catalog Number : 3PS85-80-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 80mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730022501 Catalog Number : 3PS85-90-01

Device Description : Poly-Axial Screw, Solid, Ø8.5mm x 90mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

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