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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 28 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-570-120L	FDA UDI	Class II	Active
Monster Screw System	P20-540-018S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TPR5	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-942-FL06	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-900-MNCL	FDA UDI	Class I	Active
Monster Screw System	P26-772-140F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-100-0001	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-942-4550	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-853-4720	FDA UDI	Class II	Active
Monster Screw System	P20-140-030S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-911-3500	FDA UDI	Class I	Active
Monster Screw System	P20-535-020S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-903-BASE	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-851-TP12	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-213-L018	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR10-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR1-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-2714	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-193-1620	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-213-R010	FDA UDI	Class II	Active
Monster® Screw System	P25-900-WSCD	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0005	FDA UDI	Class II	Active
Monster Screw System	P20-120-020F	FDA UDI	Class II	Active
Monster Screw System	P25-255-065S	FDA UDI	Class II	Active
Monster Screw System	P25-262-034S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-854-C042	FDA UDI	Class I	Active
Monster Screw System	P20-435-016S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-815-300L-S	FDA UDI	Class II	Active
Monster Screw System	P20-170-105F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-926-2002	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-900-0002	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-1000	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5218	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-900-TTAC-2	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P54-402-L101	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-800-300R-S	FDA UDI	Class II	Active
Monster Screw System	P26-755-095F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-200L-S	FDA UDI	Class II	Active
Monster Screw System	P20-440-024F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I511-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I310-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR10-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P01-900-2103	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOEWC-01-01	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-102-R202	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4218	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0009	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR5L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I216-S	FDA UDI	Class II	Active
Monster Screw System	P20-125-026F	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.