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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 113 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla/Gorilla Plating System	P50-653-5220	FDA UDI	Class II	Active
Monster Screw System	P20-170-084F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I507	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-SBLAT	FDA UDI	Class I	Active
Monster Screw System	P25-245-056S	FDA UDI	Class II	Active
Monster Screw System	P20-520-038S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-1002	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P99-193-2015	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-920-TLL5	FDA UDI	Class II	Active
TITAN 3-D Wedge System	PET-0910	FDA UDI	Class I	Active
Monster Screw System	P20-935-7000	FDA UDI	Class I	Active
Gorilla Plating System	P50-353-3518	FDA UDI	Class II	Active
Monster Screw System	P20-525-032L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5216	FDA UDI	Class II	Active
Monster Screw System	P20-900-5002	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-851-P021	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I207-S	FDA UDI	Class II	Active
Monster Screw System	P20-942-4000	FDA UDI	Class I	Active
Monster Screw System	P20-525-042L	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-517-0010	FDA UDI	Class I	Active
Gorilla Plating System	P50-153-4226	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4230	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-180-BL2L-S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0032	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-3011	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-000-KWC1	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-653-5240	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2540	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-PFTL	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-900-100R	FDA UDI	Class II	Active
Monster Screw System	P20-535-014S	FDA UDI	Class II	Active
Monster Screw System	P20-520-017S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-155-180R-S	FDA UDI	Class II	Active
Monster Screw System	P26-555-075F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I109	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-904-TRY1	FDA UDI	Class I	Active
Monster Screw System	P20-530-026S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-191-4035	FDA UDI	Class II	Active
Monster Screw System	P20-540-022S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-4003-1	FDA UDI	Class I	Active
Monster Screw System	P20-435-012F	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-130-4515-SK	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-198-5000	FDA UDI	Class II	Active
Monster Screw System	P20-545-048S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-510-P000	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-042F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-923-R304	FDA UDI	Class II	Active
Monster Screw System	P20-525-028S	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-L102	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-921-TLR4	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.