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Cpt®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
CPT® FDA UDI
Generic Name
Uncoated hip femur prosthesis, one-piece FDA UDI
Model / Reference
8114-00-10 FDA UDI

Identifiers

Catalog Number
00-8114-000-10 FDA UDI
Primary DI / UDI-DI
00889024145740 FDA UDI
510(k) Number
K191735 FDA UDI
K960658 FDA UDI
FDA Product Code
JDI 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
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

Cpt® by Zimmer, Inc. — 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

K191735 also covers:

K960658 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer, Inc.

Sources (1)

  • FDA UDI 95608e2f-35e0-4275-9b50-38081b3d4dba 36 fields · synced May 30, 2026