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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 14 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-140-028S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-854-C10T	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-215-3000-S	FDA UDI	Class II	Active
Monster Screw System	P26-572-080F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I116-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-981-5001	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I312-S	FDA UDI	Class II	Active
Monster® Screw System	P99-100-2712	FDA UDI	Class I	Active
Monster Screw System	P20-145-032S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-4270	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-330-150L-S	FDA UDI	Class II	Active
Monster Screw System	P26-772-170F	FDA UDI	Class II	Active
Monster Screw System	P26-550-105F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I106	FDA UDI	Class II	Active
Monster Screw System	P20-932-4500	FDA UDI	Class I	Active
Grappler Suture Anchor System	P82-240-4820-SK	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-122-0050	FDA UDI	Class II	Active
Monster Screw System	P20-120-026S	FDA UDI	Class II	Active
Monster Screw System	P20-520-014S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-3513	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-980-0009	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-5248	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-911-4700	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL5L-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-2714	FDA UDI	Class II	Active
Monster Screw System	P20-535-036S	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4234	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2009	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-230-2500-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-3518	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-003-LC06	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-R051	FDA UDI	Class II	Active
Monster Screw System	P26-555-060M	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3534	FDA UDI	Class II	Active
Monster Screw System	P20-427-018F	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-960-4416	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I412-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-066F	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-942-L110	FDA UDI	Class I	Active
Monster Screw System	P26-772-095M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL2L-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-630-175L-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-105F	FDA UDI	Class II	Active
Monster Screw System	P24-020-010L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-142-0160	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-P001	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-926-7001	FDA UDI	Class I	Active
Monster Screw System	P26-900-SCCL-1	FDA UDI	Class I	Active
Monster Screw System	P99-193-2330	FDA UDI	Class I	Active
Monster Screw System	P26-772-180F	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.