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

Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

Clear

TiLock - M719G1005300 Catalog Number : G100-5-30

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 - M719G10053000 Catalog Number : G100-5-300

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G10053200 Catalog Number : G100-5-320

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G10053400 Catalog Number : G100-5-340

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G1005350 Catalog Number : G100-5-35

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

TiLock - M719G10053600 Catalog Number : G100-5-360

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G10053800 Catalog Number : G100-5-380

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G1005400 Catalog Number : G100-5-40

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 - M719G10054000 Catalog Number : G100-5-400

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G10054200 Catalog Number : G100-5-420

Device Description : Straight Rod

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

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