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 - 00842048100201 Catalog Number : 0104-55400

Device Description : Straight Ti Rod, 5.5 X 400

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 - 00842048100218 Catalog Number : 0104-55500

Device Description : Straight Ti Rod, 5.5 X 500

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNI, MNH, OSH, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100225 Catalog Number : 0105-55030

Device Description : Curved Ti Rod, 5.5 X 30

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNH, OSH, NKB, MNI

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100232 Catalog Number : 0105-55035

Device Description : Curved Ti Rod, 5.5 X 35

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 - 00842048100249 Catalog Number : 0105-55040

Device Description : Curved Ti Rod, 5.5 X 40

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100256 Catalog Number : 0105-55045

Device Description : Curved Ti Rod, 5.5 X 45

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100263 Catalog Number : 0105-55050

Device Description : Curved Ti Rod, 5.5 X 50

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 - 00842048100270 Catalog Number : 0105-55055

Device Description : Curved Ti Rod, 5.5 X 55

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, MNH, MNI, OSH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100287 Catalog Number : 0105-55060

Device Description : Curved Ti Rod, 5.5 X 60

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 - 00842048100294 Catalog Number : 0105-55065

Device Description : Curved Ti Rod, 5.5 X 65

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNH, NKB, OSH, MNI

Prescription Use : Yes

Device Count : 1

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