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) (4) Orthosis, Spinal Pedicle Fixation (MNI) (4) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (4) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

GSO ACP1 Spinal System - M993P1505030 Catalog Number :

Device Description : Screw Remover

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO GS1 Cannulated Screw System - M9945087861 Catalog Number :

Device Description : Reduction Head Cannulated Mulit-Axial Screw

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Cannulated Screw System - M9955087911 Catalog Number :

Device Description : Reduction Head Cannulated Mulit-Axial Screw

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Cannulated Screw System - M9965087921 Catalog Number :

Device Description : Reduction Head Cannulated Mulit-Axial Screw

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

GSO GS1 Cannulated Screw System - M9975087931 Catalog Number :

Device Description : Reduction Head Cannulated Mulit-Axial Screw

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : MNI, MNH, KWP

Prescription Use : Yes

Device Count : 1

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