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 - 00815730020217 Catalog Number : 3RST55-300

Device Description : Rod, Straight, Titanium, Ø5.5mm x 300mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020224 Catalog Number : 3RST55-400

Device Description : Rod, Straight, Titanium, Ø5.5mm x 400mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020231 Catalog Number : 3RST55-500

Device Description : Rod, Straight, Titanium, Ø5.5mm x 500mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020248 Catalog Number : 3RCT55-25

Device Description : Rod, Curved, Titanium, Ø5.5mm x 25mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020255 Catalog Number : 3RCT55-30

Device Description : Rod, Curved, Titanium, Ø5.5mm 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 - 00815730020262 Catalog Number : 3RCT55-35

Device Description : Rod, Curved, Titanium, Ø5.5mm 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 - 00815730020279 Catalog Number : 3RCT55-40

Device Description : Rod, Curved, Titanium, Ø5.5mm 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 - 00815730020286 Catalog Number : 3RCT55-45

Device Description : Rod, Curved, Titanium, Ø5.5mm 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 - 00815730020293 Catalog Number : 3RCT55-50

Device Description : Rod, Curved, Titanium, Ø5.5mm 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 - 00815730020309 Catalog Number : 3RCT55-55

Device Description : Rod, Curved, Titanium, Ø5.5mm x 55mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

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