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) (10)

Premarket Exempt

No Yes

Clear

Gorilla Plating System - 00889795000002 Catalog Number : P50-053-2708

Device Description : 2.7 x 8 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 - 00889795000019 Catalog Number : P50-053-2709

Device Description : 2.7 x 9 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 - 00889795000026 Catalog Number : P50-053-2710

Device Description : 2.7 x 10 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 - 00889795000033 Catalog Number : P50-053-2711

Device Description : 2.7 x 11 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 - 00889795000040 Catalog Number : P50-053-2712

Device Description : 2.7 x 12 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 - 00889795000057 Catalog Number : P50-053-2713

Device Description : 2.7 x 13 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 - 00889795000064 Catalog Number : P50-053-2714

Device Description : 2.7 x 14 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 - 00889795000071 Catalog Number : P50-053-2715

Device Description : 2.7 x 15 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 - 00889795000088 Catalog Number : P50-053-2716

Device Description : 2.7 x 16 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 - 00889795000095 Catalog Number : P50-053-2717

Device Description : 2.7 x 17 mm Locking Plate Screw

Device Class : 2

Duns Number: 042961576

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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