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Quadra C femoral stems

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name
Quadra C femoral stems FDA UDI
Generic Name
Uncoated hip femur prosthesis, one-piece FDA UDI
Device Name
Quadra C Cemented Standard stem size 3 FDA UDI
Model / Reference
01.12.043 FDA UDI
Description
Quadra C Cemented Standard stem size 3 FDA UDI

Identifiers

Primary DI / UDI-DI
07630030802249 FDA UDI
510(k) Number
K083558 FDA UDI
FDA Product Code
JDI FDA UDI
LZO FDA UDI
GMDN Term
Uncoated hip femur prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3350 FDA UDI
888.3353 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, one-piece

Quadra C femoral stems by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated hip femur prosthesis, one-piece.

Cleared under the same submission

K083558 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medacta International

Sources (1)

  • FDA UDI 9c2b54ea-fa44-4305-818c-bf94fc6b22c7 34 fields · synced Jun 1, 2026