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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 115 of 118

Device	Model / Reference	Registries	Class	Status
Baby Gorilla®/Gorilla® Plating System	P50-353-3558	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P85-510-175U	FDA UDI	Class II	Active
Monster Screw System	P26-572-180F	FDA UDI	Class II	Active
Monster Screw System	P20-545-050S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-0010	FDA UDI	Class I	Active
Monster Screw System	P20-440-022F	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-4226	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-5216	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-4003	FDA UDI	Class I	Active
Monster Screw System	P20-125-032F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I513-S	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-980-1000	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-191-5035	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-210-0014-SK	FDA UDI	Class II	Active
FJ2000 System	P65-001-0002-SK	FDA UDI	Class I	Active
Monster® Screw System	P20-140-065L	FDA UDI	Class II	Active
Monster Screw System	P20-140-048S	FDA UDI	Class II	Active
Monster Screw System	P20-440-032S	FDA UDI	Class II	Active
Monster Screw System	P20-170-070S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-905-2027	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-032F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-250R-S	FDA UDI	Class II	Active
Monster Screw System	P26-572-110M	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I508	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P85-410-128U	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-135-0034	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-913-2011	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31P-I213-S	FDA UDI	Class II	Active
Gorilla Plating System	P53-106-L005	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-901-24TH	FDA UDI	Class I	Active
Monster Screw System	P26-572-120F	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-BOWC-2	FDA UDI	Class I	Unknown
Gorilla Plating System	P50-353-3538	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-150-0112	FDA UDI	Class I	Active
Grappler™ Suture Anchor System	P44-941-3510-S	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-4234	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-PSI-R105	FDA UDI	Class I	Active
Monster Screw System	P20-130-040F	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BR4L-S	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P99-151-P30S-1-S	FDA UDI	Class I	Active
FJ2000 System	P65-105-2220-S	FDA UDI	Class I	Active
Multi System	P99-000-AOSS	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-900-MICB	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-140-0068	FDA UDI	Class II	Active
Bun-Yo-Matic™ Lapidus Clamp System	P30-960-1211	FDA UDI	Class I	Active
FJ2000 System	P65-105-3031-S	FDA UDI	Class I	Active
Multi System	P99-191-TX06	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCWO-20-5	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-851-P032	FDA UDI	Class I	Active
Precision MIS Bunion System	P27-130-0034	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.