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 - 00842048100102 Catalog Number : 0104-55070

Device Description : Straight Ti Rod, 5.5 X 70

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100119 Catalog Number : 0104-55075

Device Description : Straight Ti Rod, 5.5 X 75

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNH, OSH, MNI, NKB

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100126 Catalog Number : 0104-55080

Device Description : Straight Ti Rod, 5.5 X 80

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, OSH, MNH, MNI

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100133 Catalog Number : 0104-55085

Device Description : Straight Ti Rod, 5.5 X 85

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 - 00842048100140 Catalog Number : 0104-55090

Device Description : Straight Ti Rod, 5.5 X 90

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 - 00842048100157 Catalog Number : 0104-55100

Device Description : Straight Ti Rod, 5.5 X 100

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 - 00842048100164 Catalog Number : 0104-55110

Device Description : Straight Ti Rod, 5.5 X 110

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 - 00842048100171 Catalog Number : 0104-55120

Device Description : Straight Ti Rod, 5.5 X 120

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 - 00842048100188 Catalog Number : 0104-55200

Device Description : Straight Ti Rod, 5.5 X 200

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : MNI, NKB, OSH, MNH

Prescription Use : Yes

Device Count : 1

F1 MPS Modular Pedicle Screw System - 00842048100195 Catalog Number : 0104-55300

Device Description : Straight Ti Rod, 5.5 X 300

Device Class : 2

Duns Number: 078812602

Premarket Exempt : No

Product Code : NKB, MNH, OSH, MNI

Prescription Use : Yes

Device Count : 1

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