Identity
- Trade Name
- EVOLUTION FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- EVOLUTION HINGE CUT THRU BOX ADAPTER, SIZE 6, LEFT FDA UDI
- Model / Reference
- E120566L FDA UDI
- Description
- EVOLUTION HINGE CUT THRU BOX ADAPTER, SIZE 6, LEFT FDA UDI
Identifiers
- Catalog Number
- E120566L FDA UDI
- Primary DI / UDI-DI
- 00192629277281 FDA UDI
- 510(k) Number
- K230563 FDA UDI
- FDA Product Code
- KRO FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 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: Joint prosthesis implantation kit, reusable
Evolution by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Joint prosthesis implantation kit, reusable.
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- APEX Knee System — OMNIlife science, Inc. · Class I
- Initia Total Hip System — Kyocera Corporation · Class I
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- Engage Partial Knee System — Engage Uni, LLC · Class II
- DFS — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K230563 also covers:
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort Orthopedics Inc.
- EVOLUTION — MicroPort 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
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI b2b12991-b259-46ec-993a-cc8ffd163e9c 36 fields · synced Jun 9, 2026