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Persona® The Personalized Knee System
FDA UDIClass II (US FDA UDI)
by Zimmer, Inc.
Identity
- Trade Name
- Persona® The Personalized Knee System FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- 00-5907-080-22 FDA UDI
Identifiers
- Catalog Number
- 00-5907-080-22 FDA UDI
- Primary DI / UDI-DI
- 00889024202931 FDA UDI
- 510(k) Number
- K150090 FDA UDI
- FDA Product Code
- JWH FDA UDIOIY FDA UDIMBH FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Persona® The Personalized Knee System by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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Cleared under the same submission
K150090 also covers:
- PERSONA® — Zimmer, Inc.
- PERSONA® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
- PERSONA® Vivacit-E® — Zimmer, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 3406dba8-e2e8-44fb-b1b4-81f61218cca4 36 fields · synced May 31, 2026