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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 7 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla®/Gorilla® Plating System	P99-930-2108	FDA UDI	Class I	Active
Gorilla Plating System	P51-903-1001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-100-BL2S-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-058F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-943-0035	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0003	FDA UDI	Class II	Active
Monster Screw System	P26-572-135M	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-1702	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-2718	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I108	FDA UDI	Class II	Active
TITAN 3-D Wedge System	PCT-006	FDA UDI	Class I	Active
Monster Screw System	P20-932-7000	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-2713	FDA UDI	Class II	Active
Monster Screw System	P20-135-016S	FDA UDI	Class II	Active
Monster Screw System	P20-145-048L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-900-0004	FDA UDI	Class I	Active
Monster Screw System	P20-135-032F	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-970-0002	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-3105-1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I309	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2524	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR5L-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-4730	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-4003-2	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-5005	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-910-TB5L	FDA UDI	Class II	Active
Monster Screw System	P99-000-316A	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-4238	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3520	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-980-1000	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-194-1840	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-SMCT	FDA UDI	Class I	Active
Grappler™ Suture Anchor System	P44-960-1055-S	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5560	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I211-S	FDA UDI	Class II	Active
Monster Screw System	P20-155-058F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-111-L002	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4216	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL3S-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-190-TL40	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-981-510R	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-207-R007	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2712	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-3514	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-3512	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-4258	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4234	FDA UDI	Class II	Active
Gorilla Plating System	P53-203-L015	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-841-AW01	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-942-RS05	FDA UDI	Class I	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.