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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 94 of 118

Device	Model / Reference	Registries	Class	Status
JAWS® Nitinol Staple System	P72-015-1515-S	FDA UDI	Class II	Active
Monster Screw System	P26-572-160M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TBV1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-844-04SM	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-135-0056	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-951-3540	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-4222	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL5S-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-250R-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4540	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-030F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-842-AC06	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0012	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-MLC1	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-4220	FDA UDI	Class II	Active
Monster Screw System	P20-545-038S	FDA UDI	Class II	Active
Gorilla Plating System	P01-900-0003	FDA UDI	Class I	Active
Monster Screw System	P20-427-036F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-954-0345	FDA UDI	Class I	Active
Monster Screw System	P20-155-044L	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-431-L101	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR5S-S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-555S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-115-3000-S	FDA UDI	Class II	Active
Monster Screw System	P20-943-4000	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-115-2500-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I111-S	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-122-0100	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-2724	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-PSI-L105	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-2713	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-CFXC-3	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLA1	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLL4-S	FDA UDI	Class II	Active
Monster Screw System	P24-027-022S	FDA UDI	Class II	Active
Monkey Rings External Fixation System	P45-962-6000	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-4254	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-R212	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-APD4	FDA UDI	Class I	Active
Monster Screw System	P20-555-042L	FDA UDI	Class II	Active
Monster Screw System	P20-135-012F	FDA UDI	Class II	Active
Monster Screw System	P20-170-072F	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R213	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I306-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-102-L103	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL5L-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0120	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P99-193-2020	FDA UDI	Class I	Active
Monster Screw System	P20-125-026S	FDA UDI	Class II	Active
Monster Screw System	P20-170-044L	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.