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Paragon 28

Last updated September 17, 2026

Information

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

Catalogue (5858)

Page 9 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P51-906-1001	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-140-0036	FDA UDI	Class II	Active
Monster Screw System	P20-900-0012	FDA UDI	Class I	Active
Monster Screw System	P20-170-076M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2518	FDA UDI	Class II	Active
Monster Screw System	P25-240-034S	FDA UDI	Class II	Active
Monster Screw System	P20-125-016S	FDA UDI	Class II	Active
Monster Screw System	P20-135-018F	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-2713	FDA UDI	Class II	Active
Monster Screw System	P25-440-038S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P99-191-LT10	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4240	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-411-L102	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-006-0323	FDA UDI	Class II	Active
Monster Screw System	P20-440-038F	FDA UDI	Class II	Active
Monster Screw System	P20-427-011F	FDA UDI	Class II	Active
Monster Screw System	P20-130-034S	FDA UDI	Class II	Active
Monster Screw System	P20-140-036S	FDA UDI	Class II	Active
Monster Screw System	P25-255-048S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-950-R106	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4255	FDA UDI	Class II	Active
Monster Screw System	P20-130-038F	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4218	FDA UDI	Class II	Active
Monster Screw System	P20-170-065S	FDA UDI	Class II	Active
Monster Screw System	P25-900-SCCL	FDA UDI	Class I	Active
Monster Screw System	P25-255-038S	FDA UDI	Class II	Active
Monster Screw System	P20-120-038F	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-410-0400	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-955-2702	FDA UDI	Class I	Active
Monster Screw System	P26-755-060F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-813-TB3U	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-198-6000	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-3513	FDA UDI	Class I	Active
Monster Screw System	P20-525-048L	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-900-0004	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR1S-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWC-01-02	FDA UDI	Class II	Active
Monster Screw System	P20-900-0013-2	FDA UDI	Class I	Active
Tenodesis Screw System	P41-040-1500-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-910-0001	FDA UDI	Class I	Active
Monster Screw System	P20-900-0021	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-199-6030-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-900-027L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-103-R004	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-214-1004	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L1-5554	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-943-L100	FDA UDI	Class I	Active
Gorilla Plating System	P50-053-2710	FDA UDI	Class II	Active
Monster Screw System	P20-140-042L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-IN02	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.