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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 101 of 118

Device	Model / Reference	Registries	Class	Status
Lesser Metatarsal Shortening System	P35-300-3527	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-911-TB1L	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-4730	FDA UDI	Class II	Active
Monster Screw System	P20-530-012S	FDA UDI	Class II	Active
Monster Screw System	P24-905-0002	FDA UDI	Class II	Active
Monster Screw System	P20-135-036S	FDA UDI	Class II	Active
TITAN 3-D Wedge System	P03-COT-1005-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2740	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-300-0004-S	FDA UDI	Class II	Active
Monster Screw System	P25-240-060S	FDA UDI	Class II	Active
Monster Screw System	P20-427-036S	FDA UDI	Class II	Active
Monster Screw System	P20-440-034S	FDA UDI	Class II	Active
Monster Screw System	P20-520-032L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-513-0003	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-PFIC	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-100-BR5S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-LL20	FDA UDI	Class I	Active
Grappler Interference Screw System	P41-910-5513	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-901-3101	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-239-1460	FDA UDI	Class II	Active
Monster Screw System	P20-135-044S	FDA UDI	Class II	Active
Monster Screw System	P20-120-042S	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2709	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-2754	FDA UDI	Class II	Active
Monster® Screw System	P99-110-4215	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-101-4121	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR2S-S	FDA UDI	Class II	Active
Monster® Screw System	P99-100-1712	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-3011-1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-910-TB3R	FDA UDI	Class II	Active
Monster Screw System	P20-545-030S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-DT07	FDA UDI	Class I	Active
Gorilla Plating System	P53-110-R203	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOEW-18-10 TRL	FDA UDI	Class II	Active
Monster Screw System	P20-170-115M	FDA UDI	Class II	Active
Monster Screw System	P20-427-020F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TBV6	FDA UDI	Class I	Active
Dynamic Syndesmosis	P80-142-1755-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-1001-14	FDA UDI	Class I	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-510-P000	FDA UDI	Class II	Active
Monster Screw System	P20-125-038F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-908-0008	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-199-5030-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-905-2435	FDA UDI	Class I	Active
Monster Screw System	P20-440-030F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-950-0005	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-4232	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-111-R002	FDA UDI	Class II	Active
Monster Screw System	P20-170-042M	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLA6	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.