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PERSONA® Persona SoluTion™

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
PERSONA® Persona SoluTion™ FDA UDI
Generic Name
Uncoated knee femur prosthesis, metallic FDA UDI
Model / Reference
42-5050-064-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00889024231351 FDA UDI
510(k) Number
K142787 FDA UDI
FDA Product Code
OIY FDA UDI
MBH FDA UDI
JWH FDA UDI
GMDN Term
Uncoated knee femur prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 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

PERSONA® Persona SoluTion™ by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142787 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 f3b13bc9-b9c8-4786-8f5b-73549ef5b96d 36 fields · synced Jun 8, 2026