Identity
- Trade Name
- Persona® FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- 110046273 FDA UDI
Identifiers
- Catalog Number
- 110046273 FDA UDI
- Primary DI / UDI-DI
- 00889024632387 FDA UDI
- 510(k) Number
- K221479 FDA UDI
- FDA Product Code
- OIY FDA UDIMBH FDA UDIJWH 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
The Persona device is a reusable, single-use orthopedic implant that provides durable and reliable support for patients with knee, patellofemoral, semi-constrained, cemented, or polymer/conductive devices. Designed to be sterilized multiple times without losing its effectiveness, this medical device meets strict safety standards and is suitable for use in various healthcare settings.
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
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- ZOCCOLI BIANCHI - con fori - 37 — GIMA SPA · Class I
Cleared under the same submission
K221479 also covers:
- Persona® — Zimmer, Inc.
- Persona® — Zimmer, Inc.
- Persona® — Zimmer, Inc.
- Persona® — Zimmer, Inc.
- Persona® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
- Persona® PPS® — Zimmer, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 5103e952-996c-4930-a2aa-ca419e2e3702 36 fields · synced Jul 31, 2026