Identity
- Trade Name
- Unicondylar Knee System FDA UDI
- Generic Name
- Unicondylar knee insert FDA UDI
- Model / Reference
- SC3405-5X-6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840843109570 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
Yes
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
Unicondylar Knee System by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Unicondylar knee insert.
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- GMK Uni — Medacta International · Class II
- SIGMA — DEPUY (IRELAND) · Class II
- GENESIS — Smith & Nephew, Inc. · Class II
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
- Globus Medical, Inc.
Sources (1)
- FDA UDI 34333c56-a6e0-4937-99c7-e48bcacb10ec 32 fields · synced Jun 1, 2026