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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 3 of 118

Device	Model / Reference	Registries	Class	Status
Monkey Rings™ External Fixation System	P45-914-0004	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5556	FDA UDI	Class II	Active
Monster Screw System	P25-245-042S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I210	FDA UDI	Class II	Active
Gorilla Plating System	P53-104-0030	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-615-175R-S	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-941-7080	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2730	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-300-4250	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-908-L011	FDA UDI	Class I	Active
Monster Screw System	P20-135-012S	FDA UDI	Class II	Active
Monster Screw System	P20-125-014F	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-2021	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3544	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0028	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4530	FDA UDI	Class II	Active
Monster Screw System	P20-525-042S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-195-1840	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-190-TL35	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-150-0017	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-109-L303	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-4230	FDA UDI	Class II	Active
Monster Screw System	P25-262-038S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-3548	FDA UDI	Class II	Active
Monster Screw System	P20-900-0010	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-515-0001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I310-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-953-TL01	FDA UDI	Class I	Active
Monster Screw System	P20-170-048F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-100-0000-05	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3546	FDA UDI	Class II	Active
Monster Screw System	P20-170-105L	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1212L	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3530	FDA UDI	Class II	Active
Monster Screw System	P20-170-084S	FDA UDI	Class II	Active
Monster Screw System	P25-445-052S	FDA UDI	Class II	Active
Monster Screw System	P20-120-017F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-415-3000-S	FDA UDI	Class II	Active
JAWS Nitinol Staple System	P71-025-2020-S	FDA UDI	Class II	Active
HammerTube™ System	P40-002-0350-SK	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-922-1001	FDA UDI	Class I	Active
Baby Gorilla® / Gorilla® Plating System	P50-453-2770	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-193-4023	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-920-TLR1	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-SB99	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-3510	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-1550	FDA UDI	Class I	Active
Monster Screw System	P25-462-065S	FDA UDI	Class II	Active
JAWS Nitinol Staple System	P71-020-2020-S	FDA UDI	Class II	Active
Monster Screw System	P20-135-026S	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.