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) (3) Screwdriver (HXX) (2) Tray, Surgical (LRP) (2) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (1) Caliper (KTZ) (1) Instrument, Bending Or Contouring (HXP) (1)

Premarket Exempt

No Yes

Clear

GSO ACP1 Anterior Cervical Plate System - M9935095200 Catalog Number :

Device Description : Variable Angle Screw

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

GSO ACP1 Anterior Cervical Plate System - M9935097000 Catalog Number :

Device Description : Implant Case

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

GSO ACP1 Anterior Cervical Plate System - M9935097010 Catalog Number :

Device Description : Instrument Case

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097100 Catalog Number :

Device Description : 2.5mm Hex Driver

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097120 Catalog Number :

Device Description : Screw Holder

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097130 Catalog Number :

Device Description : Torque Limiting Locking Screwdriver Handle

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097140 Catalog Number :

Device Description : Locking Screw Driver

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097150 Catalog Number :

Device Description : Locking Screwdriver Shaft

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097160 Catalog Number :

Device Description : Caliper - Measuring Device

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : KTZ

Prescription Use : Yes

Device Count : 1

GSO ACP1 Spinal System - M9935097190 Catalog Number :

Device Description : Plate Bender - Increase

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

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