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Summit

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
SUMMIT FDA UDI
Generic Name
Uncoated hip femur prosthesis, modular FDA UDI
Device Name
SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 3 HI 108mm FDA UDI
Model / Reference
1570-24-013 FDA UDI
Description
SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 3 HI 108mm FDA UDI

Identifiers

Catalog Number
157024013 FDA UDI
Primary DI / UDI-DI
10603295060581 FDA UDI
510(k) Number
K013352 FDA UDI
K023453 FDA UDI
K030122 FDA UDI
FDA Product Code
JDI FDA UDI
LWJ FDA UDI
GMDN Term
Uncoated hip femur prosthesis, modular FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
888.3360 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: Uncoated hip femur prosthesis, modular

Summit by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated hip femur prosthesis, modular.

Cleared under the same submission

K013352 also covers:

K023453 also covers:

K030122 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Orthopaedics, Inc.

Sources (1)

  • FDA UDI 18484723-f727-4975-8459-50718a71bc21 36 fields · synced Jun 8, 2026