Royal Oak Medical Devices LLC

Royal Oak Medical Devices LLC

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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, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

No

Clear

Royal Oak Pedicle Screw System - 00812352020007 Catalog Number :

Device Description : Set Screw

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020014 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø5.5x30mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020076 Catalog Number :

Device Description : Set Screw - Identical to part number PS5.5-4001.

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020083 Catalog Number :

Device Description : Cross Connector, Fixed 28mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020090 Catalog Number :

Device Description : Cross Connector, Fixed 31mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020106 Catalog Number :

Device Description : Cross Connector, Fixed 34mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020113 Catalog Number :

Device Description : Cross Connector, Fixed 37mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020120 Catalog Number :

Device Description : Cross Connector, Fixed 40mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020137 Catalog Number :

Device Description : Cross Connector, Variable, 40-45mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020144 Catalog Number :

Device Description : Cross Connector, Variable, 43-50mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

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