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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 12 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-31A-I209-S	FDA UDI	Class II	Active
Tenodesis Screw System	P41-930-7000	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BL10-S	FDA UDI	Class II	Active
Monster Screw System	P20-570-095L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2015	FDA UDI	Class II	Active
Monster Screw System	P20-545-070S	FDA UDI	Class II	Active
Monster Screw System	P20-155-034F	FDA UDI	Class II	Active
Tenodesis Screw System	P41-055-2500-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-911-5200	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2536	FDA UDI	Class II	Active
Monster Screw System	P20-570-130S	FDA UDI	Class II	Active
Monster Screw System	P20-120-032F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P99-150-0030	FDA UDI	Class I	Active
Monster Screw System	P26-772-170M	FDA UDI	Class II	Active
Monster Screw System	P20-145-050L	FDA UDI	Class II	Active
Monster® Screw System	P20-910-4000	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-960-3016	FDA UDI	Class I	Active
Lesser Metatarsal Shortening System	P99-151-P30M-1-S	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-102-L102	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-920-1013	FDA UDI	Class II	Active
Monster Screw System	P20-145-030F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-2745	FDA UDI	Class II	Active
Gorilla Plating System	P53-106-R202	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I517-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-200L-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3540	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2724	FDA UDI	Class II	Active
Monster Screw System	P20-570-060L	FDA UDI	Class II	Active
Monster Screw System	P20-170-100M	FDA UDI	Class II	Active
Monster Screw System	P20-130-014S	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4214	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5548	FDA UDI	Class II	Active
Monster Screw System	P26-755-065F	FDA UDI	Class II	Active
Monster Screw System	P20-140-044F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-007-LC08	FDA UDI	Class II	Active
Monster Screw System	P24-027-016S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-410-0300	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-006-5017	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-180-0180	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-1009	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-2001	FDA UDI	Class II	Active
Monster® Screw System	P99-110-4011	FDA UDI	Class I	Active
Monster Screw System	P25-445-034S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-1903	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I115-S	FDA UDI	Class II	Active
Monster® Screw System	P99-110-5513	FDA UDI	Class I	Active
Gorilla Plating System	P51-900-2001	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-4220	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL0-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-200L-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.