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 20 of 118

Device	Model / Reference	Registries	Class	Status
JAWS Nitinol Staple System	P71-015-1515-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-930-I318	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-3554	FDA UDI	Class II	Active
Monster Screw System	P20-145-042L	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I316-S	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-TRL-20-5.5	FDA UDI	Class II	Active
TenoTac Soft Tissue Fixation System	P42-022-0065-S	FDA UDI	Class II	Active
Monster Screw System	P26-572-145M	FDA UDI	Class II	Active
Small Bone Phantom Intramedullary Nail System	P30-S1-3512	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P51-912-2310	FDA UDI	Class I	Active
APEX 3D Total Ankle Replacement System	P10-931-I110	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-2712	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-455-080F	FDA UDI	Class II	Active
Gorilla Plating System	P53-103-R151	FDA UDI	Class II	Active
Monster Screw System	P20-570-065L	FDA UDI	Class II	Active
Monster Screw System	P20-920-2500	FDA UDI	Class I	Active
Monkey Rings™ External Fixation System	P45-196-6045	FDA UDI	Class II	Active
Grappler™ Suture Anchor System	P44-960-0055-S	FDA UDI	Class I	Active
Baby Gorilla/Gorilla Plating System	P50-553-5220	FDA UDI	Class II	Active
Monster Screw System	P20-170-082M	FDA UDI	Class II	Active
Monster Screw System	P20-155-056S	FDA UDI	Class II	Active
Monster Screw System	P20-125-044S	FDA UDI	Class II	Active
Monster Screw System	P20-130-044F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-958-3000	FDA UDI	Class II	Active
Monster Screw System	P20-545-034S	FDA UDI	Class II	Active
Phantom® Fibula Nail System	P36-501-3542	FDA UDI	Class II	Active
Monkey Bars™ Pin to Bar External Fixation System	P47-210-430B	FDA UDI	Class II	Active
Gorilla Plating System	P50-153-4242	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P32-350-100F	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31P-I212-S	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-31A-I407-S	FDA UDI	Class II	Active
Monster Screw System	P20-145-046F	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P50-353-3565	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-942-FL12	FDA UDI	Class I	Active
Small Bone Phantom Intramedullary Nail System	P30-000-KWT3	FDA UDI	Class I	Active
Monster Screw System	P24-020-013S	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-4242	FDA UDI	Class II	Active
Paragon 28 Bone Wedge System	AOCW-20-5.5	FDA UDI	Class II	Active
Baby Gorilla®/Gorilla® Plating System	P53-403-L112	FDA UDI	Class II	Active
Monster Screw System	P25-900-SCCB	FDA UDI	Class I	Active
Monster Screw System	P25-255-036S	FDA UDI	Class II	Active
Monster Screw System	P20-440-032F	FDA UDI	Class II	Active
Phantom Hindfoot TTC/TC Nail System	P31-415-2500-S	FDA UDI	Class II	Active
Monster Screw System	P26-572-140M	FDA UDI	Class II	Active
Baby Gorilla/Gorilla Plating System	P50-053-2026	FDA UDI	Class II	Active
APEX 3D Total Ankle Replacement System	P10-251-TLL5-S	FDA UDI	Class II	Active
Monster Screw System	P25-445-058S	FDA UDI	Class II	Active
Gorilla Plating System	P53-110-R212	FDA UDI	Class II	Active
Monster Screw System	P20-135-038S	FDA UDI	Class II	Active
Gorilla Plating System	P50-053-2728	FDA UDI	Class II	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.