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Cemented Cups

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
CEMENTED CUPS FDA UDI
Generic Name
Polyethylene acetabulum prosthesis FDA UDI
Device Name
Cemented cups (UHMWPE) Dia. 46 for head dia32mm FDA UDI
Model / Reference
Standard Cup FDA UDI
Description
Cemented cups (UHMWPE) Dia. 46 for head dia32mm FDA UDI

Identifiers

Catalog Number
5615.50.015 FDA UDI
Primary DI / UDI-DI
08033390012652 FDA UDI
510(k) Number
K112158 FDA UDI
FDA Product Code
KWZ FDA UDI
KWY FDA UDI
JDI FDA UDI
LPH FDA UDI
GMDN Term
Polyethylene acetabulum prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3310 FDA UDI
888.3390 FDA UDI
888.3350 FDA UDI
888.3358 FDA UDI
Commercial Distribution
Not 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

Cemented Cups by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K112158 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI ea7b7df9-12d4-4ede-8bde-24a9bd88a1a2 37 fields · synced May 30, 2026