PARAGON 28, INC.

Address:14445 Grasslands Dr.,Englewood,CO,80112,US

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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

Screw, fixation, bone (HWC) (9) Plate, fixation, bone (HRS) (1)

Premarket Exempt

No Yes

Clear

Gorilla Plating System - 00889795000736 Catalog Number : P50-053-4242

Device Description : 4.2 x 42 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000743 Catalog Number : P50-053-4244

Device Description : 4.2 x 44 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000750 Catalog Number : P50-053-4246

Device Description : 4.2 x 46 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000767 Catalog Number : P50-053-4248

Device Description : 4.2 x 48 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000774 Catalog Number : P50-053-4250

Device Description : 4.2 x 50 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000804 Catalog Number : P50-053-4255

Device Description : 4.2 x 55 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000835 Catalog Number : P50-053-4260

Device Description : 4.2 x 60 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000866 Catalog Number : P50-053-4265

Device Description : 4.2 x 65 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000897 Catalog Number : P50-053-4270

Device Description : 4.2 x 70 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Gorilla Plating System - 00889795000910 Catalog Number : P53-101-1012

Device Description : 28 Plate, 20 mm, 2-Hole Compression

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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