Identity
- Trade Name
- World Knee Offset Tibial Omnicut Block Slim - RMLL FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
- Model / Reference
- 122-18-0578 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215075132 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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: Orthopaedic implant aiming/guiding block, reusable
World Knee Offset Tibial Omnicut Block Slim - RMLL by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming/guiding block, reusable.
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- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Journey — Smith & Nephew, Inc. · Class I
- Unity Total Knee System — CORIN LTD · Class II
- Unity Total Knee System — CORIN LTD · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 6212b159-2648-4f4f-9153-37b091ab0e00 32 fields · synced May 31, 2026