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

Orthosis, spondylolisthesis spinal fixation (MNH) (8) ARTHROSCOPE (HRX) (2)

Premarket Exempt

Clear

Outologous Spinal Fixation System - 00813892021004 Catalog Number : SS6020

Device Description : Set Screw

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021011 Catalog Number : TL1040

Device Description : 40mm Cross Link

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021028 Catalog Number : TL1050

Device Description : 50mm Cross Link

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021035 Catalog Number : TL1060

Device Description : 60mm Cross Link

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021042 Catalog Number : TL1070

Device Description : 70mm Cross Link

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021059 Catalog Number : TL1080

Device Description : 80mm Cross Link

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021066 Catalog Number : CH2010

Device Description : Cross Link Hook

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Outologous Spinal Fixation System - 00813892021073 Catalog Number : CN3010

Device Description : Cross Link Nut

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : MNH

Prescription Use : No

Device Count : 1

Q System Arthroscope - 00813892021080 Catalog Number : AS-400

Device Description : 4mm 0º Long Arthroscope

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

Q System Arthroscope - 00813892021097 Catalog Number : AS-175S

Device Description : 3mm 30º Arthroscope

Device Class : 2

Duns Number: 068109169

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

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