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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 17 of 118

Device	Model / Reference	Registries	Class	Status
Monster® Screw System	P20-910-7000	FDA UDI	Class II	Active
Monster Screw System	P20-135-024S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOLEW-18-10	FDA UDI	Class II	Active
Monster Screw System	P20-170-080M	FDA UDI	Class II	Active
Monster Screw System	P20-520-050L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-925-0002	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-3530	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-970-0003	FDA UDI	Class I	Active
Monster Screw System	P20-941-2025	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-3522	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3018	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R000	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR4-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0016	FDA UDI	Class II	Active
Monster Screw System	P20-125-028F	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-3526	FDA UDI	Class II	Active
JAWS® Nitinol Staple System	P71-012-1212-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-0003	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0115	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-413-L212	FDA UDI	Class II	Active
Monster Screw System	P20-440-060F	FDA UDI	Class II	Active
Monster Screw System	P20-520-016S	FDA UDI	Class II	Active
Monster Screw System	P20-130-042S	FDA UDI	Class II	Active
Monster Screw System	P20-120-048F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-192-2010	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-854-WR01	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-812-TB6U	FDA UDI	Class II	Active
Multi System	P99-150-0019	FDA UDI	Class I	Active
Monster Screw System	P20-540-038S	FDA UDI	Class II	Active
Gorilla Plating System	P53-102-R002	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-901-TRY1	FDA UDI	Class II	Active
Monster Screw System	P20-555-065S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-920-1006	FDA UDI	Class I	Active
Monster Screw System	P25-455-065S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR3L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I112	FDA UDI	Class II	Active
Monster Screw System	P20-440-055S	FDA UDI	Class II	Active
Monster Screw System	P20-170-076L	FDA UDI	Class II	Active
Monster Screw System	P20-570-130M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL10-S	FDA UDI	Class II	Active
Monster Screw System	P25-262-042S	FDA UDI	Class II	Active
Monster Screw System	P20-135-022S	FDA UDI	Class II	Active
Monster Screw System	P20-427-020S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-920-0003	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-153-WS00-S	FDA UDI	Class II	Active
Monster Screw System	P25-462-054S	FDA UDI	Class II	Active
Monster Screw System	P20-525-024S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-2003	FDA UDI	Class I	Active
Monster Screw System	P25-455-054S	FDA UDI	Class II	Active
Monster® Screw System	P20-140-080L	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.