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 - 00815730020019 Catalog Number : 3RST55-25

Device Description : Rod, Straight, 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 - 00815730020026 Catalog Number : 3RST55-30

Device Description : Rod, Straight, 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 - 00815730020033 Catalog Number : 3RST55-35

Device Description : Rod, Straight, 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 - 00815730020040 Catalog Number : 3RST55-40

Device Description : Rod, Straight, 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 - 00815730020057 Catalog Number : 3RST55-45

Device Description : Rod, Straight, 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 - 00815730020064 Catalog Number : 3RST55-50

Device Description : Rod, Straight, 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 - 00815730020071 Catalog Number : 3RST55-55

Device Description : Rod, Straight, Titanium, Ø5.5mm 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 - 00815730020088 Catalog Number : 3RST55-60

Device Description : Rod, Straight, Titanium, Ø5.5mm x 60mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020095 Catalog Number : 3RST55-65

Device Description : Rod, Straight, Titanium, Ø5.5mm x 65mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

NEO Modera Pedicle Screw System - 00815730020101 Catalog Number : 3RST55-70

Device Description : Rod, Straight, Titanium, Ø5.5mm x 70mm

Device Class : 2

Duns Number: 079375910

Premarket Exempt : No

Product Code : MNI

Prescription Use : No

Device Count : 1

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