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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 8 of 118

Device	Model / Reference	Registries	Class	Status
Gorilla Plating System	P50-453-3514	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-0073	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AONLS3022	FDA UDI	Class II	Active
Monster Screw System	P20-941-4000	FDA UDI	Class I	Active
Monster Screw System	P20-155-085L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I209	FDA UDI	Class II	Active
Monster Screw System	P20-525-015S	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-045-1500-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I406-S	FDA UDI	Class II	Active
Multi System	P99-150-0096	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P32-350-075F	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-122-0050-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-LL00	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-0011LG	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-052F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-P002	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-901-RSP3	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-926-5003	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-942-L114	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-501-3548	FDA UDI	Class II	Active
Monster Screw System	P20-545-030L	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-900-0001-3	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-AND1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I413-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P99-106-6005-S	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-401-L201	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4522	FDA UDI	Class II	Active
HammerTube System	P40-293-1103	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-3520	FDA UDI	Class II	Active
Monster Screw System	P20-130-048S	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-1021	FDA UDI	Class II	Active
Monster Screw System	P20-130-032F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I218-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-920-TLR4	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2540	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-905-5001	FDA UDI	Class I	Active
Gorilla Plating System	P50-253-4230	FDA UDI	Class II	Active
Monster Screw System	P20-120-009F	FDA UDI	Class II	Active
Monster Screw System	P20-427-026F	FDA UDI	Class II	Active
Monster Screw System	P20-520-020S	FDA UDI	Class II	Active
Monster Screw System	P20-170-065L	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-901-5035	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-014-L022	FDA UDI	Class II	Active
Monster Screw System	P26-572-110F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-130-0012	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-MTPL-02	FDA UDI	Class I	Active
Monster Screw System	P20-525-034S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I107-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-915-3931	FDA UDI	Class II	Active
Monster Screw System	P99-192-1415	FDA UDI	Class I	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.