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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 11 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P50-900-LGCL	FDA UDI	Class I	Active
Monster Screw System	P26-572-165M	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-R103	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-941-AL05	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I309-S	FDA UDI	Class II	Active
HammerTube™ System	P40-002-0350-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-239-1740	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-455-095F	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3542	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-115-2000-S	FDA UDI	Class II	Active
HammerTube™ System	P40-001-0350-SK	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-3005-1	FDA UDI	Class I	Active
Monster Screw System	P20-145-028L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2036	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR4S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I507-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-908-0007	FDA UDI	Class I	Active
Monster Screw System	P20-070-WB00	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-040F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-902-1003-T	FDA UDI	Class I	Active
Monster® Screw System	P20-910-5500	FDA UDI	Class II	Active
Monster Screw System	P25-240-048S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-200R-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-930-2008	FDA UDI	Class I	Active
Monster Screw System	P20-145-042S	FDA UDI	Class II	Active
Monster Screw System	P20-535-026S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-854-D09T	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-912-1000	FDA UDI	Class II	Active
Monster® Screw System	P99-110-7020	FDA UDI	Class I	Active
Monster Screw System	P20-570-130L	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3550	FDA UDI	Class II	Active
Gorilla Plating System	P53-151-1003	FDA UDI	Class II	Active
Monster Screw System	P20-125-044F	FDA UDI	Class II	Active
Monster Screw System	P20-120-013S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-854-LG10	FDA UDI	Class I	Active
Monster Screw System	P20-155-046F	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-4265	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-910-TB2L	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-535S	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R201	FDA UDI	Class II	Active
Monster Screw System	P20-125-030F	FDA UDI	Class II	Active
Monster Screw System	P20-140-044L	FDA UDI	Class II	Active
Monster Screw System	P26-550-100M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-L304	FDA UDI	Class II	Active
Monster Screw System	P25-462-034S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-4232	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2724	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I520-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-PSI0	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	PCC-016	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.