PARAGON 28, INC.

Address:44 Riverdale Avenue,Monmouth Bch,NJ,07750,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 - 00889795000415 Catalog Number : P50-053-3544

Device Description : 3.5 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 - 00889795000422 Catalog Number : P50-053-3546

Device Description : 3.5 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 - 00889795000439 Catalog Number : P50-053-3548

Device Description : 3.5 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 - 00889795000446 Catalog Number : P50-053-3550

Device Description : 3.5 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 - 00889795000576 Catalog Number : P50-053-4210

Device Description : 4.2 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 - 00889795000583 Catalog Number : P50-053-4212

Device Description : 4.2 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 - 00889795000590 Catalog Number : P50-053-4214

Device Description : 4.2 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 - 00889795000606 Catalog Number : P50-053-4216

Device Description : 4.2 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 - 00889795000613 Catalog Number : P50-053-4218

Device Description : 4.2 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 - 00889795000620 Catalog Number : P50-053-4220

Device Description : 4.2 x 20 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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