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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 109 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P99-204-1608	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-813-TB1U	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-190-TS35	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-410-0500	FDA UDI	Class II	Active
Paratrooper™ Plantar Plate Repair System	P13-905-1035	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-653-5228	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2528	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-L002	FDA UDI	Class II	Active
Monster Screw System	P20-540-040L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I212	FDA UDI	Class II	Active
Monster Screw System	P20-155-054S	FDA UDI	Class II	Active
Monster Screw System	P20-435-040S	FDA UDI	Class II	Active
Monster Screw System	P99-110-2011	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-5255	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-MTPB	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I307	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-239-1752	FDA UDI	Class II	Active
Grappler Interference Screw System	P62-CAD-0001	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-3002	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-100-2416	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2526	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3564	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-842-AC05	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-910-6515	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P99-150-0004	FDA UDI	Class I	Active
Gorilla Plating System	P20-027-DW00	FDA UDI	Class II	Active
Monster Screw System	P20-440-014F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-192-3023	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEW-20-12	FDA UDI	Class II	Active
Monster Screw System	P20-520-034L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-921-0002	FDA UDI	Class II	Active
Multi System	P99-150-0040	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-330-1250	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3552	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-902-BASE	FDA UDI	Class I	Active
FJ2000 System	P65-001-0001-SK	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P80-950-0080	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-905-2300	FDA UDI	Class I	Active
HammerTube System	P40-900-2750	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-DT03	FDA UDI	Class I	Active
Monster Screw System	P20-570-086M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-920-TLR2	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2011	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I120-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-910-2015	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-900-SCWB	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-935-0005	FDA UDI	Class II	Active
Monster Screw System	P20-545-022S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-206-0004	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-906-TRY2	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.