GOLD STANDARD ORTHOPEDICS, LLC

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Device Class
Product Code
Premarket Exempt
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Device Description : Variable Angle Screw

Device Class : 2

Duns Number: 028008203

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Device Description : Implant Case

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Device Description : Instrument Case

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Device Description : 2.5mm Hex Driver

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Device Description : Screw Holder

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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

Device Description : Locking Screw Driver

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Device Description : Locking Screwdriver Shaft

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Device Description : Caliper - Measuring Device

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : KTZ

Prescription Use : Yes

Device Count : 1

Device Description : Plate Bender - Increase

Device Class : 1

Duns Number: 028008203

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1