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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 6 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-31A-I308-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-5236	FDA UDI	Class II	Active
Monster Screw System	P25-445-044S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-051-0005	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-653-5210	FDA UDI	Class II	Active
Monster Screw System	P20-535-048S	FDA UDI	Class II	Active
TITAN 3-D Wedge System	P03-EVN-1012-S	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-L003	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-2713	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-924-0002	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3545	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4220	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-R153	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL0-S	FDA UDI	Class II	Active
Monster Screw System	P20-570-105L	FDA UDI	Class II	Active
Monster Screw System	P20-135-050F	FDA UDI	Class II	Active
Monster Screw System	P20-120-024F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0030	FDA UDI	Class II	Active
FJ2000 System	P65-108-4313-S	FDA UDI	Class I	Active
Monster Screw System	P20-427-016S	FDA UDI	Class II	Active
Monster Screw System	P20-545-026S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-L211	FDA UDI	Class II	Active
Monster Screw System	P26-550-110F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-957-0001	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEW-22-12 TRL	FDA UDI	Class II	Active
Monster® Screw System	P25-920-4000	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-125-0140	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-150-0080	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I407-S	FDA UDI	Class II	Active
HammerTube System	P40-910-2750	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2508	FDA UDI	Class II	Active
Monster Screw System	P20-545-036L	FDA UDI	Class II	Active
Monster Screw System	P25-445-036S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-851-P041	FDA UDI	Class I	Active
Monster Screw System	P99-251-2007	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-153-2026	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-040-2000-S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-100-4020	FDA UDI	Class I	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-420B	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-014-R003	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-3534	FDA UDI	Class II	Active
Monster Screw System	P20-525-040L	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-904-1001	FDA UDI	Class I	Active
JAWS Staple System	P70-900-JAWS-1	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I320-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P80-960-5500	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-942-L120	FDA UDI	Class I	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-220-5325	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-430-2500-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-250L-S	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.