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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (8) Orthosis, Spinal Pedicle Fixation (MNI) (2) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (2) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (2)

Premarket Exempt

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Royal Oak Pedicle Screw System - 00812352020557 Catalog Number :

Device Description : Straight Rod Ø5.5x80mm

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 - 00812352020564 Catalog Number :

Device Description : Straight Rod Ø5.5x90mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020724 Catalog Number :

Device Description : Parallel PLIF Cage 22mm x 8mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020731 Catalog Number :

Device Description : Parallel PLIF Cage 22mm x 10mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020748 Catalog Number :

Device Description : Parallel PLIF Cage 22mm x 12mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020755 Catalog Number :

Device Description : Parallel PLIF Cage 22mm x 14mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020762 Catalog Number :

Device Description : Parallel PLIF Cage 22mm x 16mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020779 Catalog Number :

Device Description : Parallel PLIF Cage 26mm x 8mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020786 Catalog Number :

Device Description : Parallel PLIF Cage 26mm x 10mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352020793 Catalog Number :

Device Description : Parallel PLIF Cage 26mm x 12mm

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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