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Actis

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
ACTIS FDA UDI
Generic Name
Coated femoral stem prosthesis, one-piece FDA UDI
Device Name
ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STD COLLAR SIZE 5 Non-CE FDA UDI
Model / Reference
1010-13-050 FDA UDI
Description
ACTIS DUOFIX HIP PROSTHESIS FEMORAL STEM 12/14 TAPER CEMENTLESS STD COLLAR SIZE 5 Non-CE FDA UDI

Identifiers

Catalog Number
101013050 FDA UDI
Primary DI / UDI-DI
10603295380696 FDA UDI
510(k) Number
K150862 FDA UDI
FDA Product Code
KWY FDA UDI
KWL FDA UDI
MEH FDA UDI
LPH FDA UDI
GMDN Term
Coated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3390 FDA UDI
888.3360 FDA UDI
888.3353 FDA UDI
888.3358 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coated femoral stem prosthesis, one-piece

Actis by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated femoral stem prosthesis, one-piece.

Cleared under the same submission

K150862 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 2447cc8b-5f3a-4b2a-af6a-293588f48755 36 fields · synced Jun 1, 2026