DEGEN MEDICAL, INC.

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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) Pedicle screw spinal system, adolescent idiopathic scoliosis (OSH) (10)

Premarket Exempt

No Yes

Clear

F1 MPS Modular Pedicle Screw System - 00842048100409 Catalog Number : 0110-50050

Device Description : Screw Body Cannulated, 5.0mm X 50mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, MNI, OSH, MNH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100416 Catalog Number : 0110-50055

Device Description : Screw Body Cannulated, 5.0mm X 55mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, MNH, OSH, MNI

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100423 Catalog Number : 0110-50060

Device Description : Screw Body Cannulated, 5.0mm X 60mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNI, OSH, NKB, MNH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100430 Catalog Number : 0110-55030

Device Description : Screw Body Cannulated, 5.5mm X 30mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100447 Catalog Number : 0110-55035

Device Description : Screw Body Cannulated, 5.5mm X 35mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNH, MNI, OSH, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100454 Catalog Number : 0110-55040

Device Description : Screw Body Cannulated, 5.5mm X 40mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100461 Catalog Number : 0110-55045

Device Description : Screw Body Cannulated, 5.5mm X 45mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNH, MNI, NKB, OSH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100478 Catalog Number : 0110-55050

Device Description : Screw Body Cannulated, 5.5mm X 50mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNI, MNH, NKB, OSH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100485 Catalog Number : 0110-55055

Device Description : Screw Body Cannulated, 5.5mm X 55mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100492 Catalog Number : 0110-55060

Device Description : Screw Body Cannulated, 5.5mm X 60mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB

Prescription Use : Yes

Device Count : 1

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