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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 110 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-101-BL6S-S	FDA UDI	Class II	Active
Monkey Rings External Fixation System	P45-195-2040	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1465-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2524	FDA UDI	Class II	Active
Monster Screw System	P20-555-080L	FDA UDI	Class II	Active
Monster Screw System	P20-540-038L	FDA UDI	Class II	Active
HammerTube System	P40-CAD-LID1	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOLS3028	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-3522	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-2013	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-4212	FDA UDI	Class I	Active
Monster Screw System	P24-027-024S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I306	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR3S-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-925-0105	FDA UDI	Class II	Active
Monster Screw System	P20-942-2500	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-3532	FDA UDI	Class II	Active
Monster Screw System	P20-145-028F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-901-BASE	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R301	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0012	FDA UDI	Class II	Active
Monster Screw System	P20-170-042S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-925-6031	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-951-TBR2	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I310-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-941-AL03	FDA UDI	Class I	Active
Gorilla Plating System	P53-110-L100	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I310-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLF5	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3536	FDA UDI	Class II	Active
Monster Screw System	P20-525-022S	FDA UDI	Class II	Active
Monster Screw System	P20-155-065S	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-937-2820	FDA UDI	Class I	Active
Monster Screw System	P26-555-085F	FDA UDI	Class II	Active
Gorilla Plating System	P53-106-R205	FDA UDI	Class II	Active
Monster Screw System	P26-750-090F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-330-150R-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-910-TB6L	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-4726	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4546	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-900-5005	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-2414	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I220	FDA UDI	Class II	Active
Monster Screw System	P26-750-110F	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-925-0104	FDA UDI	Class II	Active
Monster Screw System	P20-170-095S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-3538	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-080F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I106-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-250R-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.