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

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Royal Oak Pedicle Screw System - 00812352020250 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø4.5x35mm

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 - 00812352020267 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø4.5x40mm

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 - 00812352020274 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø4.5x45mm

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 - 00812352020281 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø4.5x50mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352020298 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø5.5x35mm

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 - 00812352020304 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø5.5x40mm

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 - 00812352020311 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø5.5x45mm

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 - 00812352020328 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø5.5x50mm

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 - 00812352020335 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø6.5x30mm

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 - 00812352020342 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø6.5x35mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

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