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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 4 of 118

Device	Model / Reference	Registries	Class	Status
Paragon 28 Bone Wedge System	AOCW-20-8	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BR1L-S	FDA UDI	Class II	Active
Monster Screw System	P20-130-030F	FDA UDI	Class II	Active
Monster Screw System	P20-120-034S	FDA UDI	Class II	Active
Monster Screw System	P20-170-074S	FDA UDI	Class II	Active
Monster Screw System	P20-520-030L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5224	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-202-2000-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-201-1306	FDA UDI	Class I	Active
Monster Screw System	P25-240-058S	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-3512	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR3-S	FDA UDI	Class II	Active
Monster Screw System	P20-135-018S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-851-TBV3	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-951-TPR1	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-000-LNCL	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-0020-1	FDA UDI	Class I	Active
Monster Screw System	P20-155-048S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-815-150L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-455-110L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-901-OS01	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I420-S	FDA UDI	Class II	Active
Monster Screw System	P26-555-120F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0036	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I307-S	FDA UDI	Class II	Active
Multi System	P99-292-0915	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-180-0160	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-FL11	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-920-TFT2	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	PCC-010	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-951-3032	FDA UDI	Class I	Active
Monster Screw System	P26-550-055F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-002-LC05	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3530	FDA UDI	Class II	Active
Monster Screw System	P20-520-046S	FDA UDI	Class II	Active
Monster Screw System	P20-427-014F	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P99-151-P301-S	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I208	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3538	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2715	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-926-5001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I116-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-TRL-16-4.5	FDA UDI	Class II	Active
Monster Screw System	P26-750-070F	FDA UDI	Class II	Active
Monster Screw System	P20-120-011F	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-100-4020	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-900-027R	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-108-L001	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BR6S-S	FDA UDI	Class II	Active
Monster Screw System	P26-572-090F	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.