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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 103 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-140-060L	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-982-5101	FDA UDI	Class I	Active
Monster Screw System	P25-255-052S	FDA UDI	Class II	Active
Monster Screw System	P26-772-090M	FDA UDI	Class II	Active
Monster Screw System	P26-900-RXDL	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I311-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOEW-20-12 TRL	FDA UDI	Class II	Active
Monster Screw System	P26-550-110M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-022F	FDA UDI	Class II	Active
Gorilla Plating System	P53-106-L204	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-600-1000	FDA UDI	Class I	Active
Monster Screw System	P20-170-115L	FDA UDI	Class II	Active
Monster Screw System	P20-435-050S	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1740-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-925-0005	FDA UDI	Class II	Active
Monster Screw System	P20-435-020S	FDA UDI	Class II	Active
Monster Screw System	P20-540-060L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-003-R006	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-941-0200	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-3002	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-925-5231	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-901-0001	FDA UDI	Class I	Active
TenoTac Soft Tissue Fixation System	P42-122-0075	FDA UDI	Class II	Active
Monster® Screw System	P26-920-5000	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-125-0200	FDA UDI	Class II	Active
Monster Screw System	P20-900-0017-1	FDA UDI	Class I	Active
MgNum	P02-BVF-0005	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-615-300L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-901-3102	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-239-1760	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-455-105F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-070F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BL3S-S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-420B	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-960-0001	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-115F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-911-TB2R	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-207-L006	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-330-200R-S	FDA UDI	Class II	Active
Monster Screw System	P26-951-5055	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-854-MD01	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-0020	FDA UDI	Class I	Active
Monster Screw System	P20-555-070S	FDA UDI	Class II	Active
Monster Screw System	P20-145-030S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-115F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0060	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-0114	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P11-854-RAD1-17	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3590	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-191-TT40	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.