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Trident

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name
Trident FDA UDI
Generic Name
Combination-material acetabulum prosthesis FDA UDI
Device Name
Polyethylene Acetabular Cup FDA UDI
Model / Reference
65C-2250 FDA UDI
Description
Polyethylene Acetabular Cup FDA UDI

Identifiers

Catalog Number
65C-2250 FDA UDI
Primary DI / UDI-DI
07613327023985 FDA UDI
510(k) Number
K001956 FDA UDI
K012026 FDA UDI
FDA Product Code
JDI FDA UDI
GMDN Term
Combination-material acetabulum prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 50.0 Millimeter FDA UDI
Lumen/Inner Diameter — 22.0 Millimeter FDA UDI

Category: Combination-material acetabulum prosthesis

Trident by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Combination-material acetabulum prosthesis.

Cleared under the same submission

K001956 also covers:

K012026 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Howmedica Osteonics Corp.

Sources (1)

  • FDA UDI 30117780-3016-4d55-93cf-490d821a6c39 36 fields · synced May 30, 2026