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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 5 of 118

Device	Model / Reference	Registries	Class	Status
Small Bone Phantom Intramedullary Nail System	P30-P1-3518	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I110-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-901-RSP5	FDA UDI	Class I	Active
Monster Screw System	P20-570-100M	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R202	FDA UDI	Class II	Active
Monster Screw System	P20-135-036F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-630-200L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-902-1001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I217-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-300R-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-LL01	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-2102	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I516	FDA UDI	Class II	Active
Monster Screw System	P20-135-020F	FDA UDI	Class II	Active
Monster Screw System	P20-155-048F	FDA UDI	Class II	Active
Monster Screw System	P20-170-076F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-251-1610	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-101-BL6L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BL10-S	FDA UDI	Class II	Active
Tenodesis Screw System	P41-055-2000-S	FDA UDI	Class II	Active
Monster® Screw System	P30-110-5517	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I411-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-055F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-250R-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I414	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-902-TRY1	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-403-R211	FDA UDI	Class II	Active
Monster® Screw System	P20-140-024L	FDA UDI	Class II	Active
Monster Screw System	P20-120-042F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR6L-S	FDA UDI	Class II	Active
Gorilla Plating System	P53-153-0002	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-900-1004	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-2109	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-0111	FDA UDI	Class I	Active
Monster® Screw System	P99-110-4511	FDA UDI	Class I	Active
Gorilla Plating System	P53-109-R113	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-1022	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR1S-S	FDA UDI	Class II	Active
Monster® Screw System	P25-900-WSCL	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-965-6000-S	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1208	FDA UDI	Class I	Active
Monster Screw System	P26-572-120M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-LL04	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-854-RAD1	FDA UDI	Class I	Active
Monster Screw System	P20-900-0004	FDA UDI	Class I	Active
Monster Screw System	P20-940-5055	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-944-0002	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-048F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-440-R003	FDA UDI	Class II	Active
Specialty Instrument, Hardware Removal Caddy	SP99-CAD-0001	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.