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Paragon 28

Last updated September 17, 2026

Information

Country: US
Address: 14445 Grasslands Dr., Englewood, CO, 80112
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008650117
DUNS Number: —

Catalogue (5858)

Page 29 of 118

Device	Model / Reference	Registries	Class	Status
Gorilla Plating System	P50-053-3518	FDA UDI	Class II	Active
Monster Screw System	P26-755-115M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-956-0001	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-924-0003	FDA UDI	Class I	Active
Monster Screw System	P99-192-0915	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P99-150-HB35-SHORT	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	PLT-0505	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-930-LAT4	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5542	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-AND8	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I409	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-005-0C08	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4538	FDA UDI	Class II	Active
Monster Screw System	P20-944-3500	FDA UDI	Class I	Active
Monster Screw System	P20-570-070L	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-R252	FDA UDI	Class II	Active
Monster Screw System	P20-170-110F	FDA UDI	Class II	Active
Monster Screw System	P20-545-032L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I219-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-000-KWT4	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I312	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R1-5548	FDA UDI	Class II	Active
Monster Screw System	P20-170-070F	FDA UDI	Class II	Active
Monster Screw System	P99-192-2615	FDA UDI	Class I	Active
Monster Screw System	P20-170-036F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL4L-S	FDA UDI	Class II	Active
Monster Screw System	P20-055-WF00	FDA UDI	Class II	Active
Paratrooper™ Plantar Plate Repair System	P13-192-1415	FDA UDI	Class I	Active
JAWS Staple System	P70-921-2025	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-215-2000-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L1-5546	FDA UDI	Class II	Active
Monster Screw System	P20-170-065F	FDA UDI	Class II	Active
Monster Screw System	P20-155-036F	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR10-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0090	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-900-3012-1	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P32-350-080F	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-122-0075-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-941-AL04	FDA UDI	Class I	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-CAD-0001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I509-S	FDA UDI	Class II	Active
HammerTube System	P40-900-2800	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-924-0004	FDA UDI	Class I	Active
Monster Screw System	P20-130-028F	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-913-1623	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P99-150-0055	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I119-S	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-910-3535	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-440-L003	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I206-S	FDA UDI	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 28, 2018	Z-0662-2020	—	terminated	It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Dec 19, 2017	Z-2261-2018	—	terminated	Missing drill guide as stated in the package.