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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 105 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P99-158-0638	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I112-S	FDA UDI	Class II	Active
Gorilla Plating System	P51-901-1001	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-2734	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-913-2015	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-1013	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-912-3000	FDA UDI	Class II	Active
Monster Screw System	P20-545-055S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-FL13	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-851-TP56	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4548	FDA UDI	Class II	Active
Monster Screw System	P20-540-028S	FDA UDI	Class II	Active
HammerTube System	P99-195-1407	FDA UDI	Class I	Active
R3ACT Stabilization System	P80-930-2800	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-051-0007	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-250L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I109-S	FDA UDI	Class II	Active
Monster Screw System	P20-170-074L	FDA UDI	Class II	Active
Monster Screw System	P20-570-115L	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLA5	FDA UDI	Class II	Active
R3ACT Stabilization System	P80-900-0004-2	FDA UDI	Class I	Active
Monster Screw System	P25-455-034S	FDA UDI	Class II	Active
Monster Screw System	P20-427-024F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-3508	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P01-911-2302	FDA UDI	Class I	Active
Monster Screw System	P25-440-036S	FDA UDI	Class II	Active
Patient Specific Talus Spacer	AOPSTSXXXXS	FDA UDI	Unclassified	Active
Baby Gorilla/Gorilla Plating System	P01-911-2301	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-195-1850	FDA UDI	Class II	Active
Monster Screw System	P25-455-060S	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2730	FDA UDI	Class II	Active
Monster Screw System	P20-440-044S	FDA UDI	Class II	Active
Monster Screw System	P20-427-014S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-AND7	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-940-TT10	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I420-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-903-3001	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P80-910-2814	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL1L-S	FDA UDI	Class II	Active
Monster Screw System	P20-900-0017-2	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0105	FDA UDI	Class I	Active
Monster Screw System	P26-572-065M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2528	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1207	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I109-S	FDA UDI	Class II	Active
Grappler Interference Screw System	P62-910-0009	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-000-MISB	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3532	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-330-175R-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I209	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.