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 - 00889795000200 Catalog Number : P50-053-2736

Device Description : 2.7 x 36 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 - 00889795000217 Catalog Number : P50-053-2738

Device Description : 2.7 x 38 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 - 00889795000224 Catalog Number : P50-053-2740

Device Description : 2.7 x 40 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 - 00889795000248 Catalog Number : P50-053-3510

Device Description : 3.5 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 - 00889795000255 Catalog Number : P50-053-3512

Device Description : 3.5 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 - 00889795000262 Catalog Number : P50-053-3514

Device Description : 3.5 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 - 00889795000279 Catalog Number : P50-053-3516

Device Description : 3.5 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 - 00889795000286 Catalog Number : P50-053-3518

Device Description : 3.5 x 18 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 - 00889795000293 Catalog Number : P50-053-3520

Device Description : 3.5 x 20 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 - 00889795000309 Catalog Number : P50-053-3522

Device Description : 3.5 x 22 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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