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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 95 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-525-018S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-815-300R-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-190-TX30-09	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2728	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3524	FDA UDI	Class II	Active
HammerTube™ System	P40-001-0275-SK	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-911-TB5L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-330-175R-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-960-2495	FDA UDI	Class I	Active
Monster Screw System	P20-427-019S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I113	FDA UDI	Class II	Active
Monster Screw System	P20-520-042L	FDA UDI	Class II	Active
Monster Screw System	P20-145-018S	FDA UDI	Class II	Active
Monster Screw System	P20-140-014S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-115-1750-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P80-900-2814	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I509-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-S1-3522	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4240	FDA UDI	Class II	Active
Monster Screw System	P20-130-030S	FDA UDI	Class II	Active
Monster Screw System	P20-120-036F	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOLS3030	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR0-S	FDA UDI	Class II	Active
Monster Screw System	P20-155-075L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I118	FDA UDI	Class II	Active
Monster Screw System	P26-900-INSB	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I120	FDA UDI	Class II	Active
Monster Screw System	P26-555-065M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2034	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2516	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-965-4000-S	FDA UDI	Class II	Active
Monster Screw System	P26-750-120M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-250-1309	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR4L-S	FDA UDI	Class II	Active
Monster Screw System	P26-755-120M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-070F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-201-1002	FDA UDI	Class II	Active
Gorilla Plating System	P53-106-L201	FDA UDI	Class II	Active
Monster Screw System	P20-570-086S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-1175	FDA UDI	Class I	Active
Monster Screw System	P20-440-020S	FDA UDI	Class II	Active
Monster Screw System	P25-440-058S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-955-2003	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-2738	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-900-MISL	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-0030	FDA UDI	Class I	Active
Monster Screw System	P20-120-028F	FDA UDI	Class II	Active
Monster® Screw System	P99-110-3011	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-140-0048	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4265	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.