Is this your brand? Sign in to claim ownership.

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 16 of 118

Device	Model / Reference	Registries	Class	Status
Monkey Rings™ External Fixation System	P45-125-1140	FDA UDI	Class II	Active
Monster Screw System	P26-755-050M	FDA UDI	Class II	Active
Gorilla Plating System	P53-153-0003	FDA UDI	Class II	Active
Monster Screw System	P20-120-016S	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-208-0011	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-931-I408	FDA UDI	Class II	Active
Monkey Rings™ External Fixation System	P45-941-1002	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOLS3018	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-553-5236	FDA UDI	Class II	Active
Gorilla Plating System	P50-453-4248	FDA UDI	Class II	Active
Monster Screw System	P20-540-042L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I316	FDA UDI	Class II	Active
Monster® Screw System	P20-140-070L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-310-I411-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-944-LL22	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-930-I308	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BL2S-S	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-2746	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-450-034F	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P53-203-R017	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-772-060F	FDA UDI	Class II	Active
Gorilla Plating System	P53-104-0000	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-900-MTPS	FDA UDI	Class I	Active
APEX 3D S Total Ankle Replacement System	P11-810-TUF2	FDA UDI	Class II	Active
APEX 3D S Total Ankle Replacement System	P11-181-BL6S-S	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-903-C1LD	FDA UDI	Class I	Active
Baby Gorilla®/Gorilla® Plating System	P50-453-3556	FDA UDI	Class II	Active
Monster Screw System	P20-170-130F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I315-S	FDA UDI	Class II	Active
Monster Screw System	P26-755-110F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P99-110-4218	FDA UDI	Class I	Active
Tenodesis Screw System	P41-060-2000-S	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-R2-5560	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-202-1810	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I309	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-900-SCWL	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P53-003-L037	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P51-913-2435	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I317	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-900-GLID	FDA UDI	Class I	Active
Gorilla Plating System	P50-453-4226	FDA UDI	Class II	Active
Monster Screw System	P20-145-024S	FDA UDI	Class II	Active
Monster Screw System	P20-135-030S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-101-BL3L-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AONLS3028	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-653-4524	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P99-200-1307	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-000-LSCB	FDA UDI	Class I	Active
Monster Screw System	P26-572-175F	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-911-2735	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.