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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 21 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla® / Gorilla® Plating System	P50-453-2758	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-951-0103	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-SBANT	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2010	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TPL1	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0008	FDA UDI	Class II	Active
Monster Screw System	P20-120-011S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL3L-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-108-L012	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-085F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-111-R001	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-040R	FDA UDI	Class II	Active
Monster Screw System	P26-755-075F	FDA UDI	Class II	Active
Monster® Screw System	P20-915-4500	FDA UDI	Class II	Active
Gorilla Plating System	P51-907-0002	FDA UDI	Class I	Active
FJ2000 System	P65-002-0007	FDA UDI	Class I	Active
Monster Screw System	P20-540-032L	FDA UDI	Class II	Active
Monster Screw System	P25-445-056S	FDA UDI	Class II	Active
Monster Screw System	P26-772-080M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BL5L-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-5002	FDA UDI	Class I	Active
Monster Screw System	P20-155-050F	FDA UDI	Class II	Active
Monster Screw System	P20-145-044F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2014	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-R001	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-630-200R-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0050	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-2035	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I107	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2545	FDA UDI	Class II	Active
TITAN 3-D Wedge System	P03-905-9002	FDA UDI	Class II	Active
Monster® Screw System	P20-900-0010-1	FDA UDI	Class I	Active
Gorilla Plating System	P53-110-L212	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-950-0001	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0080	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5552	FDA UDI	Class II	Active
Monster Screw System	P20-900-0008	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-112-0180	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-003-LC27	FDA UDI	Class II	Active
Monster Screw System	P20-145-022L	FDA UDI	Class II	Active
Monster Screw System	P20-570-088M	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-140-180L-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-930-0003	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0022	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-921-TLR1	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-310-0300	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-401-R101	FDA UDI	Class II	Active
HammerTube System	P40-293-1403	FDA UDI	Class I	Active
Gorilla Plating System	P53-109-L103	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-903-BASE	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.