Genesys Orthopedics Systems LLC

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (5) Orthosis, Spinal Pedicle Fixation (MNI) (5) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (5) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (5)

Premarket Exempt

Clear

Lumbar Plate - M719G100130 Catalog Number : G10013

Device Description : Lumbar Plate System - 2 Level Standard Caddy Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100140 Catalog Number : G10014

Device Description : Lumbar Plate System - Thoracolumbar Caddy Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100150 Catalog Number : G10015

Device Description : Lumbar Plate System -Sacral Caddy Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100160 Catalog Number : G10016

Device Description : Lumbar Plate System - Variable Screw Caddy Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100170 Catalog Number : G10017

Device Description : Lumbar Plate System - Fixed Screw Caddy Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TiLock - M719G10051000 Catalog Number : G100-5-100

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

TiLock - M719G10051050 Catalog Number : G100-5-105

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G10051100 Catalog Number : G100-5-110

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

TiLock - M719G10051150 Catalog Number : G100-5-115

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

TiLock - M719G10051200 Catalog Number : G100-5-120

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

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