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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 24 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-555-052L	FDA UDI	Class II	Active
Monster Screw System	P20-120-030F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-150-0090	FDA UDI	Class I	Active
Monster Screw System	P20-155-040L	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-810-PLA2	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOLEW-18-12	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-191-6035	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-AFPL-1	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-109-L301	FDA UDI	Class II	Active
Monster Screw System	P20-435-016F	FDA UDI	Class II	Active
Monster Screw System	P20-120-010F	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-3540	FDA UDI	Class II	Active
Monster Screw System	P20-155-032F	FDA UDI	Class II	Active
Monster® Screw System	P25-900-SCBC	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-930-0001	FDA UDI	Class I	Active
Monster Screw System	P26-772-120M	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-950-L106	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I412-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I316-S	FDA UDI	Class II	Active
Monster Screw System	P26-901-0004	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2514	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-900-CASB	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-653-4512	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P99-150-FHX5	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-943-0004	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-150-0011-R	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-800-150L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLR1-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-4218	FDA UDI	Class II	Active
Monster Screw System	P20-555-060L	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-250L-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-300L-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-921-TLL3	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-131-5515-SK	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-4516	FDA UDI	Class II	Active
Monster Screw System	P26-550-120F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-102-2000-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-900-0002-3	FDA UDI	Class I	Active
Dynamic Syndesmosis	P80-142-1757-S	FDA UDI	Class II	Active
Monster Screw System	P26-550-090M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2040	FDA UDI	Class II	Active
Multi System	P99-192-2315	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-940-0002	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I409-S	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-935-0002	FDA UDI	Class I	Active
Monster Screw System	P20-170-040M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-300-150R-S	FDA UDI	Class II	Active
Monster Screw System	P26-750-050F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-441-0003	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-006-3C07	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.