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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 92 of 118

Device	Model / Reference	Registries	Class	Status
APEX 3D S Total Ankle Replacement System	P11-854-C09T	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-31A-I317-S	FDA UDI	Class II	Active
Monster Screw System	P20-900-0019	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-208-1007	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-R152	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-036F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I308	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2017	FDA UDI	Class II	Active
Monster Screw System	P20-942-3500	FDA UDI	Class I	Active
Gorilla Plating System	P50-900-BOWC-2	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I116	FDA UDI	Class II	Active
Monster Screw System	P20-555-070L	FDA UDI	Class II	Active
Monster Screw System	P20-135-034F	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-900-MIT2	FDA UDI	Class I	Active
Monster Screw System	P20-135-032S	FDA UDI	Class II	Active
Monster Screw System	P26-750-085M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-923-R303	FDA UDI	Class II	Active
Monster Screw System	P20-555-075S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I509	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-901-T154	FDA UDI	Class II	Active
Monster Screw System	P20-135-028S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-5218	FDA UDI	Class II	Active
Monster Screw System	P20-920-3000	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-014-R021	FDA UDI	Class II	Active
Gorilla Plating System	P50-900-BOW-2	FDA UDI	Class I	Active
Phantom® Fibula Nail System	P36-915-6531	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-100-BR2S-S	FDA UDI	Class II	Active
Grappler R3FLEX Stabilization System	P82-001-1237-SK	FDA UDI	Class II	Active
Monster Screw System	P20-170-082S	FDA UDI	Class II	Active
Monster Screw System	P20-540-034S	FDA UDI	Class II	Active
Monster Screw System	P20-545-018S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5232	FDA UDI	Class II	Active
Monster Screw System	P25-462-046S	FDA UDI	Class II	Active
Precision MIS Bunion System	P27-140-0052	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-130-5515-SK	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I111-S	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4250	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-922-1005	FDA UDI	Class I	Active
Monster Screw System	P20-120-040S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-615-250R-S	FDA UDI	Class II	Active
Monster Screw System	P99-110-2613	FDA UDI	Class I	Active
Monster Screw System	P20-130-018S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-PSI-L102	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I514	FDA UDI	Class II	Active
Monster Screw System	P25-240-036S	FDA UDI	Class II	Active
Monster Screw System	P20-440-048S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-16-10 TRL	FDA UDI	Class II	Active
Monster Screw System	P20-555-050S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-3552	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-056F	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.