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Cormet

FDA UDI

Class III (US FDA UDI)

by Corin Ltd

Identity

Trade Name
Cormet FDA UDI
Generic Name
Resurfacing metallic hip prosthesis FDA UDI
Device Name
Cormet resurfacing head - 56mm size 10 cemented FDA UDI
Model / Reference
179.056 FDA UDI
Description
Cormet resurfacing head - 56mm size 10 cemented FDA UDI

Identifiers

Catalog Number
179.056 FDA UDI
Primary DI / UDI-DI
05055196905153 FDA UDI
PMA Number
P050016 FDA UDI
510(k) Number
K994153 FDA UDI
FDA Product Code
NXT FDA UDI
KXA FDA UDI
GMDN Term
Resurfacing metallic hip prosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3400 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
MRI Safety
MR Conditional FDA UDI

Cormet by Corin Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K994153 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corin Ltd

Sources (1)

  • FDA UDI d1d862f6-1213-4a39-b4ee-faf16b30e8b8 36 fields · synced Jun 6, 2026