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 - B06210016540 Catalog Number : 1001-6540

Device Description : SCREW, STD PED, NON-CANN, 6.5x40mm, 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 - B06210016545 Catalog Number : 1001-6545

Device Description : SCREW, STD PED, NON-CANN, 6.5x45mm, 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 - B06210016550 Catalog Number : 1001-6550

Device Description : SCREW, STD PED, NON-CANN, 6.5x50mm, 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 - B06210016555 Catalog Number : 1001-6555

Device Description : SCREW, STD PED, NON-CANN, 6.5x55mm, 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 - B06210017530 Catalog Number : 1001-7530

Device Description : SCREW, STD PED, NON-CANN, 7.5x30mm, 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 - B06210017535 Catalog Number : 1001-7535

Device Description : SCREW, STD PED, NON-CANN, 7.5x35mm, 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 - B06210017540 Catalog Number : 1001-7540

Device Description : SCREW, STD PED, NON-CANN, 7.5x40mm, 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 - B06210017545 Catalog Number : 1001-7545

Device Description : SCREW, STD PED, NON-CANN, 7.5x45mm, 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 - B06210017550 Catalog Number : 1001-7550

Device Description : SCREW, STD PED, NON-CANN, 7.5x50mm, 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 - B06210017555 Catalog Number : 1001-7555

Device Description : SCREW, STD PED, NON-CANN, 7.5x55mm, 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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