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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 100 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P01-911-1701	FDA UDI	Class I	Active
JAWS® Nitinol Staple System	P72-018-1818-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I509-S	FDA UDI	Class II	Active
Monster Screw System	P25-445-054S	FDA UDI	Class II	Active
Monster Screw System	P20-145-055S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-545S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL2S-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I511-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-940-TT25	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I218-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I112-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-330-1030	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-140-180R-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-902-5006	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEW-20-8 TRL	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-3542	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-2750	FDA UDI	Class II	Active
Monster Screw System	P20-135-048F	FDA UDI	Class II	Active
Monster Screw System	P20-125-042S	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-960-0030	FDA UDI	Class I	Active
Monster Screw System	P20-170-115F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I519-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4214	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-951-0101	FDA UDI	Class I	Active
Monster Screw System	P20-427-010S	FDA UDI	Class II	Active
Monster Screw System	P20-140-050L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-902-TRY2	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I320	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-0052	FDA UDI	Class I	Active
FJ2000 System	P65-105-2222-S	FDA UDI	Class I	Active
Monster Screw System	P20-540-034L	FDA UDI	Class II	Active
Gorilla Plating System	P53-152-0001	FDA UDI	Class II	Active
Monster Screw System	P20-135-050S	FDA UDI	Class II	Active
Monster Screw System	P20-145-038L	FDA UDI	Class II	Active
Monster Screw System	P20-145-040L	FDA UDI	Class II	Active
Monster Screw System	P20-125-017F	FDA UDI	Class II	Active
Monster Screw System	P20-920-7000	FDA UDI	Class I	Active
TenoTac Soft Tissue Fixation System	P42-322-0095-S	FDA UDI	Class II	Active
Monster Screw System	P20-941-3000	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-102-R103	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOEW-20-10	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-R111	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-330-1150	FDA UDI	Class II	Active
Monster Screw System	P20-540-016S	FDA UDI	Class II	Active
Monster Screw System	P20-125-010S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-920-1001	FDA UDI	Class I	Active
Lesser Metatarsal Shortening System	P35-920-0357	FDA UDI	Class I	Active
Monster Screw System	P26-750-075M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I309-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-ML01	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.