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Paragon 28

Last updated September 17, 2026

Information

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

Catalogue (5858)

Page 19 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-900-0013	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-960-3416	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-915-2632	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-942-L116	FDA UDI	Class I	Active
Monster Screw System	P26-772-125M	FDA UDI	Class II	Active
Monster Screw System	P26-901-0003	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-970-0007	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-111-0200	FDA UDI	Class II	Active
Monster® Screw System	P25-910-5500	FDA UDI	Class II	Active
Monster Screw System	P20-120-013F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL2-S	FDA UDI	Class II	Active
Paratrooper™ Plantar Plate Repair System	P13-000-WEIL-SK	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P85-000-316T	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-2714	FDA UDI	Class II	Active
Monster Screw System	P20-125-038S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I112-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-192-2515	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-1001	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P99-150-2013	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0130	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-980-5001	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-MTPP	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-3536	FDA UDI	Class II	Active
JAWS Nitinol Staple System	P71-108-0808-S	FDA UDI	Class II	Active
Monster Screw System	P20-145-070L	FDA UDI	Class II	Active
Monster Screw System	P20-427-010F	FDA UDI	Class II	Active
Monster Screw System	P20-120-038S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-102-L203	FDA UDI	Class II	Active
JAWS Staple System	P71-012-1212-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I218-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-931-35LT	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-155-180L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-903-5006	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4536	FDA UDI	Class II	Active
Monster Screw System	P26-555-070F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I512-S	FDA UDI	Class II	Active
Tenodesis Screw System	P41-930-6500	FDA UDI	Class I	Active
Monster Screw System	P26-755-085M	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-L113	FDA UDI	Class II	Active
Monster Screw System	P20-140-036F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-075F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-1001	FDA UDI	Class I	Active
Monster Screw System	P20-900-5001	FDA UDI	Class I	Active
Monster Screw System	P20-530-014S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-223-0078	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I211	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-903-C1BS	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-140-270R-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-514-0001	FDA UDI	Class II	Active
Monster Screw System	P20-570-072M	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.