GOLD STANDARD ORTHOPEDICS, 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 Interlaminal (KWP) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

No Yes

Clear

GSO GS1 Spinal System - M9935011250 Catalog Number :

Device Description : Set Screw for 5mm Rod System

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935011251 Catalog Number :

Device Description : Set Screw for Rod System

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012120 Catalog Number :

Device Description : Standard Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012121 Catalog Number :

Device Description : Standard Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012130 Catalog Number :

Device Description : Standard Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012140 Catalog Number :

Device Description : Standard Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012141 Catalog Number :

Device Description : Standard Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012150 Catalog Number :

Device Description : Wide Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012151 Catalog Number :

Device Description : Wide Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Spinal System - M9935012160 Catalog Number :

Device Description : Wide Tip Hook

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

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