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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 22 of 118

Device	Model / Reference	Registries	Class	Status
Monster Screw System	P20-540-048L	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-0001	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUA6	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3020	FDA UDI	Class II	Active
Monster Screw System	P99-110-1712	FDA UDI	Class I	Active
Monster Screw System	P20-535-028S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-064F	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-540-0003	FDA UDI	Class I	Active
Gorilla Plating System	P50-900-UNVC-3	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P53-110-R222	FDA UDI	Class II	Active
Gorilla Plating System	P50-353-2714	FDA UDI	Class II	Active
Monster Screw System	P20-555-056L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-205-L005	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOLS3014	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I520-S	FDA UDI	Class II	Active
Monster Screw System	P26-772-065M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-430-1500-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-191-LR10	FDA UDI	Class II	Active
Monster Screw System	P99-190-TX30	FDA UDI	Class II	Active
Monster Screw System	P20-525-038S	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-930-0035	FDA UDI	Class II	Active
Multi System	P99-150-0003	FDA UDI	Class I	Active
Monster Screw System	P25-245-054S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0018	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-930-0001	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-455-080L	FDA UDI	Class II	Active
Monster Screw System	P20-145-026L	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2508	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I406-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-L2-5550	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I514-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-TRL-18-4.5	FDA UDI	Class II	Active
Gorilla Plating System	P53-109-R003	FDA UDI	Class II	Active
Monster Screw System	P99-192-2330	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-100-BL1L-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-300R-S	FDA UDI	Class II	Active
Lesser Metatarsal Shortening System	P35-920-0468	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-3003	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-851-TBV5	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P51-980-5010-16	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-100F	FDA UDI	Class II	Active
Patient Specific Talus Spacer	AOPSTSXXXXS-TI	FDA UDI	Unclassified	Active
Baby Gorilla®/Gorilla® Plating System	P99-191-AF10	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-051-1013	FDA UDI	Class II	Active
Monster Screw System	P20-570-060M	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P99-150-2005-05	FDA UDI	Class I	Active
Phantom Hindfoot TTC/TC Nail System	P31-600-175L-S	FDA UDI	Class II	Active
Monster Screw System	P20-135-044F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-020F	FDA UDI	Class II	Active
Monster® Screw System	P25-910-6200	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.