Orthopedic Sciences Inc

Address:3020 Old Ranch Pkwy Ste 300,SEAL BEACH,CA,90740,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

PLATE, FIXATION, BONE (HRS) (7) Orthosis, spondylolisthesis spinal fixation (MNH) (3)

Premarket Exempt

Clear

Titanium-TSY™ Shoulder Plate - 00813892020700 Catalog Number : TCS-025

Device Description : 25mm Titanium Compression Screw

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Titanium-TSY™ Shoulder Plate - 00813892020717 Catalog Number : TCS-030

Device Description : 30mm Titanium Compression Screw

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Titanium-TSY™ Shoulder Plate - 00813892020724 Catalog Number : TCS-035

Device Description : 35mm Titanium Compression Screw

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Titanium-TSY™ Shoulder Plate - 00813892020731 Catalog Number : TSP-125

Device Description : 125° Titanium-TSY™ Shoulder Plate

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Titanium-TSY™ Shoulder Plate - 00813892020748 Catalog Number : TSP-130

Device Description : 130° Titanium-TSY™ Shoulder Plate

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Titanium-TSY™ Shoulder Plate - 00813892020755 Catalog Number : TSP-135

Device Description : 135° Titanium-TSY™ Shoulder Plate

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Titanium-TSY™ Shoulder Plate - 00813892020762 Catalog Number : TSP-140

Device Description : 140° Titanium-TSY™ Shoulder Plate

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRS

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892020779 Catalog Number : PS6030

Device Description : 6.0 X 30mm Titanium Pedicle Screw Self Tapping

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892020786 Catalog Number : PS6035

Device Description : 6.0 X 35mm Titanium Pedicle Screw Self Tapping

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892020793 Catalog Number : PS6040

Device Description : 6.0 X 40mm Titanium Pedicle Screw Self Tapping

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

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