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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

Dymaxeon® - 00815500020317 Catalog Number : 06.2550B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø4.5 x50mm (VIOLET)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020324 Catalog Number : 06.2555B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø4.5 x55mm (VIOLET)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020331 Catalog Number : 06.2560B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø4.5 x60mm (VIOLET)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020348 Catalog Number : 06.2565B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø4.5 x65mm (VIOLET)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020355 Catalog Number : 06.2570B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø4.5 x70mm (VIOLET)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020362 Catalog Number : 06.2635B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø5 x35mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020379 Catalog Number : 06.2640B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø5 x40mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020386 Catalog Number : 06.2645B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø5 x45mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020393 Catalog Number : 06.2650B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø5 x50mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020409 Catalog Number : 06.2655B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø5 x55mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 2

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