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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 98 of 118

Device	Model / Reference	Registries	Class	Status
Monkey Rings™ External Fixation System	P45-125-1160	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-108-R111	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-901-5175	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-851-TPL4	FDA UDI	Class I	Active
Monster Screw System	P26-931-5500	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I314-S	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-900-BASE	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-153-2022	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-L101	FDA UDI	Class II	Active
Monster Screw System	P20-540-050L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-300L-S	FDA UDI	Class II	Active
Multi System	PET-0912	FDA UDI	Class I	Active
TenoTac Soft Tissue Fixation System	P99-192-0910	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I408	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-901-PP24	FDA UDI	Class I	Active
Tenodesis Screw System	P41-070-2500-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-LL03	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-2302	FDA UDI	Class I	Active
Monster Screw System	P26-755-075M	FDA UDI	Class II	Active
Tenodesis Screw System	P41-930-5500	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-135-0066	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-430S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I112-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-WB00	FDA UDI	Class II	Active
Monster Screw System	P26-900-50CN	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-196-5035	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-112-2002	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2716	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-921-R005	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-921-0004	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3510	FDA UDI	Class II	Active
Monster Screw System	P20-170-125M	FDA UDI	Class II	Active
Monster Screw System	P26-572-115F	FDA UDI	Class II	Active
Monster Screw System	P20-125-017S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-APD3	FDA UDI	Class I	Active
Monster Screw System	P20-540-040S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR2L-S	FDA UDI	Class II	Active
Monster Screw System	P20-570-048S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-954-0001	FDA UDI	Class II	Active
Monster Screw System	P25-240-065S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-941-LAZM	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-926-5004	FDA UDI	Class I	Active
Monster Screw System	P20-125-015S	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R001	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-R102	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-100-1015-01	FDA UDI	Class II	Active
R3ACT Stabilization System	P99-307-0910	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-653-4534	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-005-0010	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-3544	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.