Osseus Fusion Systems, LLC

Address:1931 Greenville Avenue,Dallas,TX,75206,US

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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) (8) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (8) Bit, Drill (HTW) (1) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (1) Intervertebral Fusion Device With Bone Graft, Thoracic (PHM) (1) Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (1)

Premarket Exempt

Clear

Pisces-SA - B02617500032 Catalog Number : 1750-0032

Device Description : Drill, Variable Angle

Device Class : 1

Duns Number: 933442068

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Pisces-SA - B0601700S096 Catalog Number : 1700-S096S

Device Description : 23x29x09, 16°, Sterile, Standalone ALIF Interbody, PISCES-SA

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MAX, PHM, OVD

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B062100100000J Catalog Number : 1001-0000 to 1010-9999

Device Description : The Osseus Black Diamond Pedicle Screw System is a top loading, multiple compone The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210011020 Catalog Number : 1001-1020

Device Description : SET SCREW, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210012035 Catalog Number : 1001-2035

Device Description : ROD, STRAIGHT, PERC, 5.5x35mm, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210012040 Catalog Number : 1001-2040

Device Description : ROD, STRAIGHT, PERC, 5.5x40mm, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210012045 Catalog Number : 1001-2045

Device Description : ROD, STRAIGHT, PERC, 5.5x45mm, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210012050 Catalog Number : 1001-2050

Device Description : ROD, STRAIGHT, PERC, 5.5x50mm, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210012055 Catalog Number : 1001-2055

Device Description : ROD, STRAIGHT, PERC, 5.5x55mm, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Black Diamond Pedicle Screw System - B06210012060 Catalog Number : 1001-2060

Device Description : ROD, STRAIGHT, PERC, 5.5x60mm, BLK DIAMOND

Device Class : 2

Duns Number: 933442068

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

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