VERTIFLEX, INC.

VERTIFLEX, INC.

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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

Prosthesis, Spinous Process Spacer/Plate (NQO) (10)

Premarket Exempt

No

Clear

Superion Driver - 00884662000123 Catalog Number : 100-9108

Device Description : Superion Driver

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Inserter - 00884662000130 Catalog Number : 100-9110

Device Description : Superion Inserter

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Grasping Forceps - 00884662000147 Catalog Number : 100-9112

Device Description : Superion Grasping Forceps

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Interspinous Gauge - 00884662000154 Catalog Number : 100-9115

Device Description : Superion Interspinous Gauge

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Interspinous Reamer - 00884662000178 Catalog Number : 100-9117

Device Description : Superion Interspinous Reamer

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Sterilization Tray - 00884662000185 Catalog Number : 100-9119

Device Description : Superion Sterilization Tray

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Retractor - 00884662000192 Catalog Number : 100-9126

Device Description : Superion Retractor

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Mallet - 00884662000208 Catalog Number : 100-9127

Device Description : Superion Mallet

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Interspinous Spacer - 00884662000222 Catalog Number : 100-9808

Device Description : Superion Interspinous Spacer, 8mm

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

Superion Interspinous Spacer - 00884662000246 Catalog Number : 100-9810

Device Description : Superion Interspinous Spacer, 10mm

Device Class : 3

Duns Number: 005235436

Premarket Exempt : No

Product Code : NQO

Prescription Use : Yes

Device Count : 1

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