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

Orthopedic Manual Surgical Instrument (LXH) (7) Awl (HWJ) (1) Bit, Drill (HTW) (1) Instrument, Bending Or Contouring (HXP) (1)

Premarket Exempt

No Yes

Clear

GSO ACP1 Spinal System - M9935097200 Catalog Number :

Device Description : Plate Bender - Decrease

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097220 Catalog Number :

Device Description : Awl

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HWJ

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097230 Catalog Number :

Device Description : Variable Drill Guide

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097240 Catalog Number :

Device Description : Fixed Drill Guide

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097260 Catalog Number :

Device Description : Soft Tissue Sleeve

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097280 Catalog Number :

Device Description : Plate Holder

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097300 Catalog Number :

Device Description : Drill Bit with Stop

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097310 Catalog Number :

Device Description : Palm Handle with AO Quick Connect

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097330 Catalog Number :

Device Description : Pin Inserter

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097350 Catalog Number :

Device Description : Single Use temporary Fixation Pin

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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