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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 18 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D S Total Ankle Replacement System	P11-181-BR2S-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-054F	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3514	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-900-0002-2	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-951-TBV3	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P10-912-2450	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BL5L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I116-S	FDA UDI	Class II	Active
Monster Screw System	P26-900-RXDB	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-4210	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-L210	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-540-0000	FDA UDI	Class I	Active
Monster Screw System	P99-110-2711	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-014-L003	FDA UDI	Class II	Active
Monster Screw System	P20-435-018S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-2716	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-910-2519	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-250R-S	FDA UDI	Class II	Active
Gorilla Plating System	P51-950-0014	FDA UDI	Class I	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-950-0001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-942-RS03	FDA UDI	Class I	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-100-2414	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-900-0002	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-653-5234	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2519	FDA UDI	Class II	Active
Gorilla Plating System	P53-105-R001	FDA UDI	Class II	Active
Monster Screw System	P20-570-082M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-950-0004	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR5-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I118-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-DT17	FDA UDI	Class I	Active
Monster Screw System	P26-901-SMCP	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-207-L007	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2740	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-910-TB3L	FDA UDI	Class II	Active
Specialty Instrument	SP27-943-0040	FDA UDI	Class I	Active
Monster Screw System	P20-155-060S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-RS11	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-128-130R-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-125-1220	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-421-R202	FDA UDI	Class II	Active
Monster Screw System	P20-140-046F	FDA UDI	Class II	Active
Monster Screw System	P20-535-022S	FDA UDI	Class II	Active
Monster Screw System	P20-125-011F	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4248	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL4-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-901-RGF1	FDA UDI	Class I	Active
Monster® Screw System	P20-915-5500	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0038	FDA UDI	Class II	Active
FJ2000 System	P65-001-0004-SK	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.