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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 23 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-435-014S	FDA UDI	Class II	Active
Monster Screw System	P20-555-040S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I516-S	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-070-2000-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I108-S	FDA UDI	Class II	Active
Monster Screw System	P26-772-180M	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-4216	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-503-0020	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3520	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-980-5010-23	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-951-TPR4	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P99-150-2007	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-4265	FDA UDI	Class II	Active
Monster Screw System	P20-570-040S	FDA UDI	Class II	Active
Patient Specific Talus Spacer	AOPSTSXXXXL-TI	FDA UDI	Unclassified	Active
Monkey Rings™ External Fixation System	P45-940-1001	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-910-3527	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2510	FDA UDI	Class II	Active
Monster Screw System	P20-530-040S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I418-S	FDA UDI	Class II	Active
Grappler Interference Screw System	P99-197-1620	FDA UDI	Class I	Active
Grappler Interference Screw System	P41-045-1000-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-851-TP56	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-201-1406	FDA UDI	Class I	Active
Lesser Metatarsal Shortening System	P35-900-0001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-842-AC03	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-4738	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-005-0013	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-R153	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2514	FDA UDI	Class II	Active
Gorilla Plating System	P53-104-0210	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-902-3016	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P32-350-115F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-250R-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUA1	FDA UDI	Class II	Active
Monster Screw System	P20-555-036S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I514	FDA UDI	Class II	Active
Monster® Screw System	P99-100-4312	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-911-4500	FDA UDI	Class I	Active
Monster® Screw System	P20-900-5004-1	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-2736	FDA UDI	Class II	Active
Monster Screw System	P25-440-048S	FDA UDI	Class II	Active
Monster Screw System	P20-530-050S	FDA UDI	Class II	Active
FJ2000 System	P65-105-2013-S	FDA UDI	Class I	Active
Monster Screw System	P20-570-100S	FDA UDI	Class II	Active
Monster Screw System	P20-170-072L	FDA UDI	Class II	Active
Monster Screw System	P20-435-042F	FDA UDI	Class II	Active
Monster Screw System	P20-145-034F	FDA UDI	Class II	Active
Monster Screw System	P20-900-MH70-1	FDA UDI	Class I	Active
Grappler™ Suture Anchor System	P44-110-4515-SK	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.