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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 108 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-130-026F	FDA UDI	Class II	Active
Monster Screw System	P20-120-030S	FDA UDI	Class II	Active
Monster Screw System	P25-255-060S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-198-1000	FDA UDI	Class I	Active
Monster Screw System	P20-520-038L	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0028	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-513-0004	FDA UDI	Class I	Active
Monster Screw System	P99-998-0023	FDA UDI	Class I	Active
Precision MIS Bunion System	P99-150-0160	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-310-0120	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR1S-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-SMC1	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-3550	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-150-0341	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-4246	FDA UDI	Class II	Active
Monster Screw System	P26-900-INSL	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-415-2000-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-950-0103	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-941-0340	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-455-095L	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L1-5550	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-026F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-108-L112	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3538	FDA UDI	Class II	Active
Gorilla Plating System	P53-210-0007	FDA UDI	Class II	Active
Monster Screw System	P20-035-DW00	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I412	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I414-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-901-3001	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-170-3000	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-209-R008	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-140-270L-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-1703	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-135-0018	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	P51-950-0001	FDA UDI	Class I	Active
Monster Screw System	P26-900-72SF	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P99-150-1007	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2013	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2545	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I506-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-1310	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-101-BL3L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4516	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-5232	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	PST-0002	FDA UDI	Class I	Active
Monster Screw System	P26-572-095M	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLF6	FDA UDI	Class II	Active
Monster Screw System	P24-905-0001	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3538	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.