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Djo Surgical

FDA UDI

Class II (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name
DJO SURGICAL FDA UDI
Generic Name
Metal-backed elbow ulna prosthesis FDA UDI
Device Name
DISC ULNA 5X115MM LT W/ E+ BRNG FDA UDI
Model / Reference
540-55-115 FDA UDI
Description
DISC ULNA 5X115MM LT W/ E+ BRNG FDA UDI

Identifiers

Primary DI / UDI-DI
00190446254515 FDA UDI
510(k) Number
K013042 FDA UDI
FDA Product Code
JDC FDA UDI
GMDN Term
Metal-backed elbow ulna prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Metal-backed elbow ulna prosthesis

Djo Surgical by Encore Medical, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal-backed elbow ulna prosthesis.

Cleared under the same submission

K013042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Encore Medical, L.p.

Sources (1)

  • FDA UDI 14f989e3-18f8-48c3-b7ed-61626b114afb 34 fields · synced May 30, 2026