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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 112 of 118

Device	Model / Reference	Registries	Class	Status
Precision MIS Bunion System	P27-931-30LT	FDA UDI	Class I	Active
Monster Screw System	P20-135-046F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I220-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5554	FDA UDI	Class II	Active
Monster Screw System	P26-555-120M	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-553-4512	FDA UDI	Class II	Active
Monster Screw System	P99-900-1005	FDA UDI	Class I	Active
Monster Screw System	P99-192-1110	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-215-2000-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-R211	FDA UDI	Class II	Active
Monster Screw System	P20-140-040L	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-851-GR02	FDA UDI	Class I	Active
Monster Screw System	P20-155-042F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3558	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4222	FDA UDI	Class II	Active
Monster Screw System	P20-170-044F	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUA2	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-191-6045	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-200L-S	FDA UDI	Class II	Active
Tenodesis Screw System	P41-060-1500-S	FDA UDI	Class II	Active
Monster Screw System	P26-772-155F	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3516	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I518-S	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P99-151-P302-S	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-903-CAD2	FDA UDI	Class I	Active
Monster Screw System	P20-530-016S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-TRL-18-6.5	FDA UDI	Class II	Active
Monster Screw System	P20-525-050L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-208-0009	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-940-3902	FDA UDI	Class II	Active
Monster Screw System	P26-550-080F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-211-0003	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-AND3	FDA UDI	Class I	Active
Monster Screw System	P20-525-046L	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-LSFC-1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-944-LL15	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5546	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-031L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2518	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0020	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I111-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-350-120F	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BL3L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-3102	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0005	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-940-3901	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0064	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0022	FDA UDI	Class II	Active
Monster Screw System	P20-540-036L	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-941-4310-S	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.