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 - M719G10051750 Catalog Number : G100-5-175

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 - M719G10051800 Catalog Number : G100-5-180

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 - M719G10051850 Catalog Number : G100-5-185

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 - M719G10051900 Catalog Number : G100-5-190

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 - M719G10051950 Catalog Number : G100-5-195

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 - M719G10052000 Catalog Number : G100-5-200

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 - M719G10052200 Catalog Number : G100-5-220

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 - M719G10052400 Catalog Number : G100-5-240

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 - M719G10052600 Catalog Number : G100-5-260

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 - M719G10052800 Catalog Number : G100-5-280

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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