Identity
- Trade Name
- Persona® FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Model / Reference
- 42-5781-005-01 FDA UDI
Identifiers
- Catalog Number
- 42-5781-005-01 FDA UDI
- Primary DI / UDI-DI
- 00880304809222 FDA UDI
- 510(k) Number
- K161592 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Osteotomy guide, reusable
Persona® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osteotomy guide, reusable.
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- Profix — Smith & Nephew, Inc. · Class II
- QUANTUM — IN2BONES · Class I
- Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
- UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I
- Truliant CC — Exactech, Inc. · Class II
Cleared under the same submission
K161592 also covers:
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, Inc.
- Persona® Partial Knee System — Biomet Orthopedics, 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 d2ac5309-c82b-4c55-bd59-8a03a03d18be 36 fields · synced Jun 8, 2026