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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 15 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P50-900-SMCL	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P99-996-0010	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I319-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P54-402-R101	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-R152	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I218	FDA UDI	Class II	Active
Monster Screw System	P20-570-080M	FDA UDI	Class II	Active
Monster Screw System	P20-545-048L	FDA UDI	Class II	Active
Monster Screw System	P20-435-014F	FDA UDI	Class II	Active
Monster Screw System	P20-440-055F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-413-R112	FDA UDI	Class II	Active
Monster Screw System	P20-120-018S	FDA UDI	Class II	Active
Gorilla Plating System	P53-154-0003	FDA UDI	Class II	Active
Monster Screw System	P25-255-046S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I216	FDA UDI	Class II	Active
Monster Screw System	P20-170-050S	FDA UDI	Class II	Active
Monster Screw System	P20-435-010F	FDA UDI	Class II	Active
Monster Screw System	P99-190-TT10	FDA UDI	Class II	Active
Monster Screw System	P20-145-022S	FDA UDI	Class II	Active
Monster Screw System	P20-135-028F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-903-CLD2	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-422-R201	FDA UDI	Class II	Active
Monster Screw System	P20-155-040F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4544	FDA UDI	Class II	Active
Multi System	P99-190-SL06	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-102-L201	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-194-2050	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3522	FDA UDI	Class II	Active
Monster Screw System	P20-520-011S	FDA UDI	Class II	Active
Monster Screw System	P25-262-050S	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2740	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3562	FDA UDI	Class II	Active
Monster Screw System	P24-027-012S	FDA UDI	Class II	Active
Monster Screw System	P20-140-040F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TBV5	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-941-AW01	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-2726	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-S1-3526	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-KWCL	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I311-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-3006-1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-100-BL6S-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3516	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-940-0001	FDA UDI	Class I	Active
Grappler Interference Screw System	P41-910-8513	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-111-L001	FDA UDI	Class II	Active
Monster Screw System	P20-435-038S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-815-350L-S	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-2022	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL5S-S	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.