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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 99 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-100-BR3S-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOLS3026	FDA UDI	Class II	Active
Monster Screw System	P25-440-060S	FDA UDI	Class II	Active
Monster Screw System	P20-427-028F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TPR2	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-981-510L	FDA UDI	Class I	Active
Monster Screw System	P26-900-RXDI	FDA UDI	Class I	Active
Monster Screw System	P25-255-058S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-910-3214	FDA UDI	Class II	Active
Monster® Screw System	P20-910-4500	FDA UDI	Class II	Active
Gorilla Plating System	P53-101-3012	FDA UDI	Class II	Active
Monster Screw System	P20-125-028S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BL6S-S	FDA UDI	Class II	Active
Monster Screw System	P26-750-115F	FDA UDI	Class II	Active
Monster Screw System	P20-570-055S	FDA UDI	Class II	Active
Monster Screw System	P20-540-028L	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-210-0028-SK	FDA UDI	Class II	Active
Monster Screw System	P20-170-080F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-851-L001	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-983-5005	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-000-CASE	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-207-L008	FDA UDI	Class II	Active
Monster Screw System	P26-572-160F	FDA UDI	Class II	Active
Monster Screw System	P20-570-076S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-225-0000	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P99-107-6005-S	FDA UDI	Class I	Active
HammerTube™ System	P40-001-0275-S	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-022-0065-SK	FDA UDI	Class II	Active
Gorilla Plating System	P53-107-2015	FDA UDI	Class II	Active
Monster Screw System	P20-530-032S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P85-310-1105	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-L151	FDA UDI	Class II	Active
Monster Screw System	P20-525-030S	FDA UDI	Class II	Active
Monster Screw System	P20-555-038S	FDA UDI	Class II	Active
Monster Screw System	P20-155-075S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-970-0001	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-199-6035-S	FDA UDI	Class II	Active
Monster Screw System	P20-427-017S	FDA UDI	Class II	Active
Monster Screw System	P20-140-060S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P99-100-4630	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-921-4018	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-004-L008	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-3616	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-615-175L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I410	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-555B	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-401-R201	FDA UDI	Class II	Active
Monster Screw System	P20-944-4000	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-4526	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-101-100L	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.