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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 13 of 118

Device	Model / Reference	Registries	Class	Status
Phantom® Fibula Nail System	P36-920-6816	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-951-TPR3	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-911-TB6L	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-4238	FDA UDI	Class II	Active
Monster Screw System	P20-120-015S	FDA UDI	Class II	Active
Monster® Screw System	P99-100-2613	FDA UDI	Class I	Active
Monster Screw System	P25-462-048S	FDA UDI	Class II	Active
Monster Screw System	P20-435-036F	FDA UDI	Class II	Active
Monster Screw System	P20-525-019S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-003-L006	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-R002	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-901-5042	FDA UDI	Class I	Active
Monster Screw System	P20-170-120M	FDA UDI	Class II	Active
Monster Screw System	P20-140-032F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I120	FDA UDI	Class II	Active
Monster Screw System	P20-145-024F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0066	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-455-100L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I413	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-191-TR10	FDA UDI	Class II	Active
Monster Screw System	P20-145-028S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWO-16-8	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	PMT-1905	FDA UDI	Class I	Active
HammerTube™ System	P40-002-0350-S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-140-130R-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-3107-1	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2028	FDA UDI	Class II	Active
Monster Screw System	P26-750-110M	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-901-BASE	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-940-L104	FDA UDI	Class I	Active
Monster Screw System	P20-145-034S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-134-180L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-908-0012	FDA UDI	Class I	Active
Monster Screw System	P99-193-1415	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I509	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3540	FDA UDI	Class II	Active
Multi System	P99-150-1241	FDA UDI	Class I	Active
Monster Screw System	P20-540-048S	FDA UDI	Class II	Active
TITAN 3-D Wedge System	P03-900-T3DC-2	FDA UDI	Class I	Active
Paragon 28 Bone Wedge System	AOCW-16-10	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2520	FDA UDI	Class II	Active
Monster Screw System	P20-920-3500	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I107-S	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-960-1000	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I112	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0040	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0056	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-20-4.5	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-4252	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P80-239-1764	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.