Osseus Fusion Systems, LLC

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

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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) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

Clear

Black Diamond Pedicle Screw System - B06210014550 Catalog Number : 1001-4550

Device Description : SCREW, STD PED, NON-CANN, 4.5x50mm, 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 - B06210014555 Catalog Number : 1001-4555

Device Description : SCREW, STD PED, NON-CANN, 4.5x55mm, 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 - B06210015530 Catalog Number : 1001-5530

Device Description : SCREW, STD PED, NON-CANN, 5.5x30mm, 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 - B06210015535 Catalog Number : 1001-5535

Device Description : SCREW, STD PED, NON-CANN, 5.5x35mm, 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 - B06210015540 Catalog Number : 1001-5540

Device Description : SCREW, STD PED, NON-CANN, 5.5x40mm, 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 - B06210015545 Catalog Number : 1001-5545

Device Description : SCREW, STD PED, NON-CANN, 5.5x45mm, 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 - B06210015550 Catalog Number : 1001-5550

Device Description : SCREW, STD PED, NON-CANN, 5.5x50mm, 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 - B06210015555 Catalog Number : 1001-5555

Device Description : SCREW, STD PED, NON-CANN, 5.5x55mm, 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 - B06210016530 Catalog Number : 1001-6530

Device Description : SCREW, STD PED, NON-CANN, 6.5x30mm, 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 - B06210016535 Catalog Number : 1001-6535

Device Description : SCREW, STD PED, NON-CANN, 6.5x35mm, 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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