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

Clear

Royal Oak Pedicle Screw System - 00812352020458 Catalog Number :

Device Description : Straight Rod Ø5.5x100mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020465 Catalog Number :

Device Description : Straight Rod Ø5.5x110mm

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 - 00812352020472 Catalog Number :

Device Description : Straight Rod Ø5.5x120mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020489 Catalog Number :

Device Description : Straight Rod Ø5.5x150mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020496 Catalog Number :

Device Description : Straight Rod Ø5.5x180mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020502 Catalog Number :

Device Description : Straight Rod Ø5.5x200mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020519 Catalog Number :

Device Description : Straight Rod Ø5.5x40mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020526 Catalog Number :

Device Description : Straight Rod Ø5.5 x 400mm

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 - 00812352020533 Catalog Number :

Device Description : Straight Rod Ø5.5x50mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020540 Catalog Number :

Device Description : Straight Rod Ø5.5x70mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

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