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 - 00815730020118 Catalog Number : 3RST55-75

Device Description : Rod, Straight, Titanium, Ø5.5mm x 75mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020125 Catalog Number : 3RST55-80

Device Description : Rod, Straight, Titanium, Ø5.5mm 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 - 00815730020132 Catalog Number : 3RST55-90

Device Description : Rod, Straight, Titanium, Ø5.5mm x 90mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020149 Catalog Number : 3RST55-100

Device Description : Rod, Straight, Titanium, Ø5.5mm x 100mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020156 Catalog Number : 3RTS55-110

Device Description : Rod, Straight, Titanium, Ø5.5mm 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 - 00815730020163 Catalog Number : 3RST55-120

Device Description : Rod, Straight, Titanium, Ø5.5mm 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 - 00815730020170 Catalog Number : 3RST55-130

Device Description : Rod, Straight, Titanium, Ø5.5mm x 130mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020187 Catalog Number : 3RST55-140

Device Description : Rod, Straight, Titanium, Ø5.5mm x 140mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020194 Catalog Number : 3RST55-150

Device Description : Rod, Straight, Titanium, Ø5.5mm x 150mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020200 Catalog Number : 3RST55-200

Device Description : Rod, Straight, Titanium, Ø5.5mm x 200mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

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