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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 107 of 118

Device	Model / Reference	Registries	Class	Status
Small Bone Phantom Intramedullary Nail System	P30-952-2720	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-653-5248	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-STR0	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P99-150-0007	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-330-175L-S	FDA UDI	Class II	Active
Monster® Screw System	P20-915-2500	FDA UDI	Class II	Active
Monster Screw System	P20-435-024S	FDA UDI	Class II	Active
Monster Screw System	P20-435-046F	FDA UDI	Class II	Active
Monster Screw System	P26-572-115M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-FL01	FDA UDI	Class I	Active
TITAN 3-D Wedge System	P03-EVN-0012-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2732	FDA UDI	Class II	Active
Monster Screw System	P20-545-034L	FDA UDI	Class II	Active
Monster Screw System	P20-525-048S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-200-1306	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-955-0100	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-008-LC05	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-011-R001	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL3L-S	FDA UDI	Class II	Active
Monster Screw System	P20-570-115S	FDA UDI	Class II	Active
Monster Screw System	P25-931-5500	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-080F	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5552	FDA UDI	Class II	Active
JAWS® Nitinol Staple System	P72-020-2020-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-517-0002	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-923-L303	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-109-L302	FDA UDI	Class II	Active
Monster Screw System	P20-900-0031	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-2738	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-410-0400	FDA UDI	Class II	Active
Monster Screw System	P20-545-046L	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5538	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0014	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4534	FDA UDI	Class II	Active
Monster Screw System	P20-545-036S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-403-R112	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4248	FDA UDI	Class II	Active
Monster Screw System	P20-170-130L	FDA UDI	Class II	Active
Monster Screw System	P20-140-036L	FDA UDI	Class II	Active
Monster Screw System	P20-170-050F	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4210	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLR5-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR4S-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-503-0001	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-910-TB1L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL4-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I316	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOHT20	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P99-192-2920	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-4002	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.