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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 1 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-145-034L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-842-AC01	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-930-2006	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-191-SL10	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR2-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2715	FDA UDI	Class II	Active
Monster Screw System	P20-155-080F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-940-0030	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-014-R022	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0050	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-108-R112	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-455-085L	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2708	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-SBNST	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I110-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-980-5101	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3534	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-930-0027	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-901-DISH	FDA UDI	Class I	Active
Grappler Interference Screw System	P41-910-4015	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-110-R221	FDA UDI	Class II	Active
Monster Screw System	P20-555-054S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-201-1002-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3510	FDA UDI	Class II	Active
Monster Screw System	P99-110-2112	FDA UDI	Class I	Active
Monster Screw System	P20-155-080L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-400-1500-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3526	FDA UDI	Class II	Active
Monster Screw System	P25-900-CASL	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-3530	FDA UDI	Class II	Active
Monster Screw System	P20-120-008S	FDA UDI	Class II	Active
Monster Screw System	P26-555-070M	FDA UDI	Class II	Active
Monster Screw System	P20-170-036S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-900-CASL	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-140-0024	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I313	FDA UDI	Class II	Active
Monster Screw System	P20-125-024S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-330-1075	FDA UDI	Class II	Active
Monster® Screw System	P99-110-3520	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-006-2666	FDA UDI	Class II	Active
Monster® Screw System	P25-920-4500	FDA UDI	Class I	Active
Monster Screw System	P20-170-095L	FDA UDI	Class II	Active
Multi System	PET-0908	FDA UDI	Class I	Active
TITAN 3-D Wedge System	P03-950-0004	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-102-0005	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0030	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3570	FDA UDI	Class II	Active
Monster Screw System	P25-245-060S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-APD2	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-5240	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.