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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 114 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D Total Ankle Replacement System	P10-952-TL00-05	FDA UDI	Class II	Active
Multi System	P99-000-316T	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-944-TCC2	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-925-0106	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-909-CAD1	FDA UDI	Class I	Active
Monster Screw System	P20-435-050F	FDA UDI	Class II	Active
Monster Screw System	P20-145-060S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-DT12	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-192-1032	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4240	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-18-10	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-250-1608	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-110-2720	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-190-TS30	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BL1L-S	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-854-D10S	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-310-1105	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-DT13	FDA UDI	Class I	Active
Monster Screw System	P26-900-INST	FDA UDI	Class I	Active
Monster Screw System	P20-540-030L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I310	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-950-0002	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-1004-2	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-PSI-L104	FDA UDI	Class I	Active
Monster Screw System	P20-125-019F	FDA UDI	Class II	Active
Monster Screw System	P26-550-115M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-941-PSI1	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-134-270R-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-310-0200	FDA UDI	Class II	Active
Monster Screw System	P20-140-024F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I318-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-002-LC38	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-4234	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-1002	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-310-I308-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-753-4726	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-908-0004	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-600-1000-S	FDA UDI	Class I	Active
Monster Screw System	P20-555-090S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-923-R301	FDA UDI	Class II	Active
Monster Screw System	P26-755-085F	FDA UDI	Class II	Active
Tenodesis Screw System	P41-930-0001	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-101-BL2S-S	FDA UDI	Class II	Active
Monster Screw System	P25-900-TRAY	FDA UDI	Class I	Active
Monster Screw System	P20-530-034S	FDA UDI	Class II	Active
Monster Screw System	P20-170-088L	FDA UDI	Class II	Active
Monster Screw System	P20-435-044F	FDA UDI	Class II	Active
Multi System	P99-150-0038	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-053-2538	FDA UDI	Class II	Active
Gorilla Plating System	P53-201-0003	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.