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 - 00812352020359 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø6.5x40mm

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 - 00812352020366 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø6.5x45mm

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 - 00812352020373 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø6.5x50mm

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 - 00812352020380 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø6.5x55mm

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 - 00812352020397 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø7.5x30mm

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 - 00812352020403 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø7.5x35mm

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 - 00812352020410 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø7.5x40mm

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 - 00812352020427 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø7.5x45mm

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 - 00812352020434 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø7.5x50mm

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 - 00812352020441 Catalog Number :

Device Description : 5.5mm Pedicle Screw Assembly Ø7.5x55mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

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