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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® - 00815500020010 Catalog Number : 06.1201B

Device Description : SINGLE ROD CONNECTOR

Device Class : 2

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Dymaxeon® - 00815500020027 Catalog Number : 06.1202B

Device Description : DOUBLE ROD CONNECTOR

Device Class : 2

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Dymaxeon® - 00815500020034 Catalog Number : 06.2100B

Device Description : DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW CAP

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020041 Catalog Number : 06.2235B

Device Description : DYMAXEON OPEN MONOAXIAL 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® - 00815500020058 Catalog Number : 06.2240B

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

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020065 Catalog Number : 06.2245B

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

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020072 Catalog Number : 06.2250B

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

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020089 Catalog Number : 06.2255B

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

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020096 Catalog Number : 06.2260B

Device Description : DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5 x60mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 2

Dymaxeon® - 00815500020102 Catalog Number : 06.2265B

Device Description : DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5 x65mm (YELLOW)

Device Class :

Duns Number: 043841348

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 2

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