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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 2 of 118

Device	Model / Reference	Registries	Class	Status
Gorilla Plating System	P53-103-L053	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I314-S	FDA UDI	Class II	Active
Monster Screw System	P26-772-185F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-900-0003-1	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-140-0054	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P01-911-2101	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-5214	FDA UDI	Class II	Active
Multi System	P99-000-AOMN	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOLEW-22-10	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I512-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-999-30CW	FDA UDI	Class I	Active
Grappler™ Suture Anchor System	P44-970-0001-SK	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I116-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-921-TLL5	FDA UDI	Class II	Active
Monster Screw System	P20-570-110S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I108-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-5246	FDA UDI	Class II	Active
Monster Screw System	P20-570-044S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-4MMC	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-101-BR4L-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-194-2140	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BR5L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TPL5	FDA UDI	Class I	Active
Monster Screw System	P26-550-055M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-TCR1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I411	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I118-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I510-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0000	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-310-0030	FDA UDI	Class II	Active
Monster Screw System	P20-570-090S	FDA UDI	Class II	Active
Monster Screw System	P26-550-080M	FDA UDI	Class II	Active
Monster Screw System	P20-155-052F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-009-L002	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-175L-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-1902	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5546	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-854-D10T	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-520-2000	FDA UDI	Class I	Active
Gorilla Plating System	P51-907-0004	FDA UDI	Class I	Active
Monster Screw System	P20-900-0002	FDA UDI	Class I	Active
Monster Screw System	P20-570-105M	FDA UDI	Class II	Active
Monster Screw System	P20-170-060S	FDA UDI	Class II	Active
Monster Screw System	P20-130-028S	FDA UDI	Class II	Active
Monster Screw System	P20-120-034F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-213-L012	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-2756	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3522	FDA UDI	Class II	Active
Monster Screw System	P99-192-2323	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-208-0007	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.