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) (9) Orthosis, Spinal Pedicle Fixation (MNI) (1) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (1) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (1)

Premarket Exempt

Clear

Royal Oak IBFD Implant System - 00812352020809 Catalog Number :

Device Description : Parallel PLIF Cage 26mm 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 - 00812352020816 Catalog Number :

Device Description : Parallel PLIF Cage 26mm 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 - 00812352020861 Catalog Number :

Device Description : TLIF Cage 25mm 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 - 00812352020878 Catalog Number :

Device Description : TLIF Cage 25mm 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 - 00812352020885 Catalog Number :

Device Description : TLIF Cage 25mm 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 - 00812352020892 Catalog Number :

Device Description : TLIF Cage 25mm 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 - 00812352020908 Catalog Number :

Device Description : TLIF Cage 25mm 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 - 00812352021288 Catalog Number :

Device Description : Royal Oak IBFD Instrument Set Case 1

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak IBFD Implant System - 00812352021295 Catalog Number :

Device Description : Royal Oak IBFD Instrument Set Case 2

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Royal Oak Pedicle Screw System - 00812352021301 Catalog Number :

Device Description : Royal Oak Pedicle Screw Instrument Set Case 1

Device Class : 2

Duns Number: 017825896

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

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