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 - 00842048100300 Catalog Number : 0105-55070

Device Description : Curved Ti Rod, 5.5 X 70

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100317 Catalog Number : 0105-55075

Device Description : Curved Ti Rod, 5.5 X 75

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 - 00842048100324 Catalog Number : 0105-55080

Device Description : Curved Ti Rod, 5.5 X 80

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNI, OSH, MNH, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100331 Catalog Number : 0105-55085

Device Description : Curved Ti Rod, 5.5 X 85

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 - 00842048100348 Catalog Number : 0105-55090

Device Description : Curved Ti Rod, 5.5 X 90

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 - 00842048100355 Catalog Number : 0105-55100

Device Description : Curved Ti Rod, 5.5 X 100

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNH, NKB, MNI, OSH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100362 Catalog Number : 0110-50030

Device Description : Screw Body Cannulated, 5.0mm X 30mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100379 Catalog Number : 0110-50035

Device Description : Screw Body Cannulated, 5.0mm X 35mm

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 - 00842048100386 Catalog Number : 0110-50040

Device Description : Screw Body Cannulated, 5.0mm X 40mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100393 Catalog Number : 0110-50045

Device Description : Screw Body Cannulated, 5.0mm X 45mm

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : OSH, NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

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