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Paragon 28

Last updated September 17, 2026

Information

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

Catalogue (5858)

Page 26 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P99-193-1623	FDA UDI	Class I	Active
Gorilla Plating System	P53-106-R003	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-046F	FDA UDI	Class II	Active
Monster Screw System	P26-755-080M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I520-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-401-L211	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-920-1004	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-4245	FDA UDI	Class II	Active
Monster Screw System	P20-125-022S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-2710	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-2303	FDA UDI	Class I	Active
Monster Screw System	P20-535-032S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-009-R001	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-913-2842	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P80-239-1754	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I507-S	FDA UDI	Class II	Active
Monster Screw System	P26-750-065M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2513	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-913-1640	FDA UDI	Class I	Active
Gorilla Plating System	P53-110-L102	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-910-SCKT	FDA UDI	Class I	Active
Bun-Yo-Matic™ Lapidus Clamp System	P31-941-0100	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-4002-1	FDA UDI	Class I	Active
Monster Screw System	P20-170-080L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I412-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I320-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0032	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-653-5212	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-580-1000	FDA UDI	Class I	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1201L	FDA UDI	Class I	Active
Grappler Interference Screw System	P41-050-2500-S	FDA UDI	Class II	Active
Monster Screw System	P26-755-060M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I518-S	FDA UDI	Class II	Active
Monster Screw System	P20-125-048F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-101-0000-03	FDA UDI	Class I	Active
Monster Screw System	P20-440-046S	FDA UDI	Class II	Active
Monster Screw System	P20-060-WD00	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I410-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-900-CSSB	FDA UDI	Class I	Active
Monster Screw System	P26-772-175F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-TCR2	FDA UDI	Class I	Active
Tenodesis Screw System	P41-930-6000	FDA UDI	Class I	Active
Monster Screw System	P26-900-50SL	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-900-CASB	FDA UDI	Class I	Active
Gorilla Plating System	P53-106-R201	FDA UDI	Class II	Active
Monster Screw System	P99-172-1520	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I115	FDA UDI	Class II	Active
Monster Screw System	P20-145-020L	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3556	FDA UDI	Class II	Active
Grappler Suture Anchor System	P82-211-0028-SK	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.