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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 10 of 118

Device	Model / Reference	Registries	Class	Status
MgNum	P02-BVF-AUX1	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-3545	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-615-250L-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-223-0118	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-SB01	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I515-S	FDA UDI	Class II	Active
JAWS Staple System	P70-921-0810	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-615-175L-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-955-2002	FDA UDI	Class II	Active
Monster Screw System	P20-030-DW00	FDA UDI	Class II	Active
Monster Screw System	P26-555-085M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-150R-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-905-0001	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P80-239-1750	FDA UDI	Class II	Active
Monster® Screw System	P20-910-2000	FDA UDI	Class II	Active
HammerTube System	P40-CAD-INS1	FDA UDI	Class I	Active
Monster Screw System	P25-440-052S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TP01	FDA UDI	Class I	Active
Monster Screw System	P26-772-100M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR2S-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-1001-23	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I416-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-902-0001	FDA UDI	Class I	Active
HammerTube™ System	P40-002-0350-SK	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-L201	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2038	FDA UDI	Class II	Active
Monster Screw System	P20-435-020F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-038F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-901-5142	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I115-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	PST-1005	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-2710	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5228	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLF3	FDA UDI	Class II	Active
Monster Screw System	P20-155-060F	FDA UDI	Class II	Active
Monster Screw System	P20-540-020S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-PSI-R104	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-944-TCC4	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-150R-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-AND6	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-403-L212	FDA UDI	Class II	Active
Monster Screw System	P20-155-026F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I210-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-901-5145	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-401-L101	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4520	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-4218	FDA UDI	Class II	Active
Monster Screw System	P20-900-0017	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-922-1004	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I312-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.