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Persona®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
PERSONA® FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Model / Reference
42-5398-005-00 FDA UDI

Identifiers

Primary DI / UDI-DI
00889024247000 FDA UDI
510(k) Number
K121771 FDA UDI
FDA Product Code
MBH FDA UDI
JWH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3565 FDA UDI
888.3560 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K121771 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 f8be885b-2e4d-4ccf-86bf-77a46512735d 36 fields · synced Jun 8, 2026