Identity
- Trade Name
- ZUK FDA UDI
- Generic Name
- Unicondylar knee insert FDA UDI
- Device Name
- Articular Surface Size 1 9mm FDA UDI
- Model / Reference
- 00584202109 FDA UDI
- Description
- Articular Surface Size 1 9mm FDA UDI
Identifiers
- Catalog Number
- 00584202109 FDA UDI
- Primary DI / UDI-DI
- 00885556619988 FDA UDI
- 510(k) Number
- K033363 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Unicondylar knee insert 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Unicondylar knee insert
Zuk by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Unicondylar knee insert.
- Alliant Biotech — Medisurge · Class II
- Vivacit-E® — Zimmer, Inc. · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- MOTO Partial Knee System - Medial — Medacta International · Class II
- GMK Uni — Medacta International · Class II
- SIGMA — DEPUY (IRELAND) · Class II
- MOTO Partial Knee System — Medacta International · Class II
- iDuo® iPoly™ Insert Kit — Conformis, Inc. · Class II
Cleared under the same submission
K033363 also covers:
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, Inc.
- ZUK — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 9611614d-9a59-4713-8a7d-ae2845ae9357 36 fields · synced Jun 8, 2026