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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 102 of 118

Device	Model / Reference	Registries	Class	Status
Small Bone Phantom Intramedullary Nail System	P30-000-KWT1	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-0008-1	FDA UDI	Class I	Active
Gorilla Plating System	P53-109-L111	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I511-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-193-2515	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-024F	FDA UDI	Class II	Active
Monster Screw System	P20-145-050F	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-910-8015	FDA UDI	Class I	Active
Monster Screw System	P24-020-009L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-005-3C07	FDA UDI	Class II	Active
Monster Screw System	P20-170-086S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-1001-16	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-942-R112	FDA UDI	Class I	Active
Monster Screw System	P26-555-080M	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-2718	FDA UDI	Class II	Active
Monster Screw System	P26-572-170F	FDA UDI	Class II	Active
Gorilla Plating System	P53-104-0212	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-2730	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-932-3500	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0095	FDA UDI	Class I	Active
Monster Screw System	P25-262-036S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P99-150-HX35	FDA UDI	Class I	Active
Monster Screw System	P20-170-086L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-196-6035	FDA UDI	Class II	Active
Monster Screw System	P20-525-010S	FDA UDI	Class II	Active
Monster Screw System	P20-170-046L	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0010	FDA UDI	Class II	Active
Monster Screw System	P20-145-040F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-830-350R-S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-410-0200	FDA UDI	Class II	Active
Monster Screw System	P26-550-060M	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-854-C12S	FDA UDI	Class I	Active
Monster Screw System	P26-550-065M	FDA UDI	Class II	Active
Monster Screw System	P20-125-034F	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3534	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-915-7200	FDA UDI	Class II	Active
Gorilla Plating System	P53-104-0045	FDA UDI	Class II	Active
Tenodesis Screw System	P41-900-BASE	FDA UDI	Class I	Active
Monster Screw System	P26-772-150M	FDA UDI	Class II	Active
Monster Screw System	P20-435-032S	FDA UDI	Class II	Active
Gorilla Plating System	P53-151-0002	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1747-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-950-0003	FDA UDI	Class II	Active
Tenodesis Screw System	P41-040-1000-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4216	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-943-0040	FDA UDI	Class I	Active
Monster Screw System	P20-545-038L	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-3534	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-941-0320	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-920-1007	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.