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Paragon 28

Last updated September 17, 2026

Information

Country: US
Address: 14445 Grasslands Dr., Englewood, CO, 80112
Website: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008650117
DUNS Number: —

Catalogue (5858)

Page 25 of 118

Device	Model / Reference	Registries	Class	Status
Phantom Hindfoot TTC/TC Nail System	P31-772-065F	FDA UDI	Class II	Active
Monster Screw System	P20-900-0017-3	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-100F	FDA UDI	Class II	Active
Monster Screw System	P26-572-070F	FDA UDI	Class II	Active
Monster Screw System	P26-750-055F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-200R-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I113-S	FDA UDI	Class II	Active
Monster Screw System	P26-555-115F	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L1-5544	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-900-0001-2	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-2732	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3522	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-FL05	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-813-TB2U	FDA UDI	Class II	Active
Monster Screw System	P20-140-044S	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2722	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-014-L002	FDA UDI	Class II	Active
JAWS Nitinol Staple System	P71-008-0808-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2717	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-001-0C08	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-3524	FDA UDI	Class II	Active
Monster Screw System	P26-572-155F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-110-L222	FDA UDI	Class II	Active
Monster Screw System	P20-145-040S	FDA UDI	Class II	Active
Monster Screw System	P20-155-065L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-965-5000	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-851-4BAR	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEW-22-10	FDA UDI	Class II	Active
AVTRAC MTP Revision System	P01-901-1101-S	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-2748	FDA UDI	Class II	Active
Monster Screw System	P20-120-018F	FDA UDI	Class II	Active
Monster Screw System	P20-155-030S	FDA UDI	Class II	Active
Monster Screw System	P20-140-026F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3554	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-112-0200	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3014	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWO-16-6	FDA UDI	Class II	Active
Monster® Screw System	P20-140-022L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-046F	FDA UDI	Class II	Active
Monster Screw System	P20-540-026S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I508-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P99-150-HB35	FDA UDI	Class I	Active
Monster Screw System	P26-755-100M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I415-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-900-0002-1	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-901-3002	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-134-130L-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-310-0060	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	PST-0001	FDA UDI	Class I	Active
Monster Screw System	P26-750-075F	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.