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Paragon 28

Last updated September 17, 2026

Information

Country: US
Address: 14445 Grasslands Dr., Englewood, CO, 80112
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008650117
DUNS Number: —

Catalogue (5858)

Page 97 of 118

Device	Model / Reference	Registries	Class	Status
HammerTube™ System	P40-002-0275-SK	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-SMCB	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-812-TB4U	FDA UDI	Class II	Active
Gorilla Plating System	P53-104-0208	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2513	FDA UDI	Class II	Active
Monster Screw System	P20-570-078M	FDA UDI	Class II	Active
Monster Screw System	P20-145-036F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-921-TLR2	FDA UDI	Class II	Active
Grappler Interference Screw System	P41-960-0020	FDA UDI	Class I	Active
Monster Screw System	P26-772-080F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BL2L-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2530	FDA UDI	Class II	Active
Monster Screw System	P20-545-024S	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-131-4515-SK	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5238	FDA UDI	Class II	Active
Monster Screw System	P25-462-052S	FDA UDI	Class II	Active
Monster Screw System	P25-440-054S	FDA UDI	Class II	Active
Monster Screw System	P20-900-5007	FDA UDI	Class I	Active
Patient Specific Talus Spacer	AOPSTSXXXXL	FDA UDI	Unclassified	Active
Gorilla Plating System	P53-106-L202	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-005-0008	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-315-200R-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I120-S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-153-2512	FDA UDI	Class II	Active
Monster Screw System	P20-130-036S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-P1-3542	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-403-L201	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-4256	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-250-TLL5-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-0005	FDA UDI	Class I	Active
Monster Screw System	P20-944-2700	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-921-TLL1	FDA UDI	Class II	Active
Monster Screw System	P20-120-044F	FDA UDI	Class II	Active
Monster Screw System	P20-440-028S	FDA UDI	Class II	Active
Baby Gorilla® / Gorilla® Plating System	P50-453-2775	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-955-4202	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-125-0180	FDA UDI	Class II	Active
Dynamic Syndesmosis	P80-142-1442-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-942-L118	FDA UDI	Class I	Active
Monster Screw System	P20-045-WD00	FDA UDI	Class II	Active
Monster Screw System	P20-435-046S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-120F	FDA UDI	Class II	Active
HammerTube System	P40-920-2707	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-204-0005	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-913-2842-03	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P51-901-1101	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-421-L201	FDA UDI	Class II	Active
Monster Screw System	P20-427-022F	FDA UDI	Class II	Active
Gorilla Plating System	P50-253-4265	FDA UDI	Class II	Active
Monster Screw System	P20-520-018S	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.