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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 111 of 118

Device	Model / Reference	Registries	Class	Status
Bun-Yo-Matic™ Lapidus Clamp System	P30-100-5310	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P80-239-1452	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-100-5493	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-130-0020	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4522	FDA UDI	Class II	Active
Monster Screw System	P25-245-050S	FDA UDI	Class II	Active
Monster Screw System	P20-900-0003	FDA UDI	Class I	Active
Monster Screw System	P20-570-105S	FDA UDI	Class II	Active
Monster Screw System	P20-130-032S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-905-2842	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-4250	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-930-2106	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-914-0001	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-431-L201	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0006	FDA UDI	Class II	Active
Monster Screw System	P20-120-032S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-413-L112	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R100	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-PSI4	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-4220	FDA UDI	Class II	Active
Monster Screw System	P20-120-024S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I118	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2718	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-2716	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-102-0001	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I514-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-1003	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I410	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4210	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3546	FDA UDI	Class II	Active
Gorilla Plating System	P53-151-0005	FDA UDI	Class II	Active
Monster Screw System	P20-120-012S	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3550	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-125-1200	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-952-3000	FDA UDI	Class I	Active
Tenodesis Screw System	P41-055-1500-S	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-3011	FDA UDI	Class II	Active
Monster Screw System	P20-140-032S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-940-0001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I216-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-047R	FDA UDI	Class II	Active
TITAN 3-D Wedge System	P03-900-T3DC-1	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5556	FDA UDI	Class II	Active
Monster Screw System	P25-445-060S	FDA UDI	Class II	Active
Monster Screw System	P99-190-TJ25	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-900-1003	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-043R	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-045F	FDA UDI	Class II	Active
Monster Screw System	P25-240-056S	FDA UDI	Class II	Active
Monster® Screw System	P99-110-3320	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.