Identity
- Trade Name
- MONDRIAN ALIF FDA UDI
- Generic Name
- Ceramic spinal interbody fusion cage FDA UDI
- Device Name
- MONDRIAN ALIF Cage, Titanium, 15Deg., W34xL23, H15mm FDA UDI
- Model / Reference
- 120.1355 FDA UDI
- Description
- MONDRIAN ALIF Cage, Titanium, 15Deg., W34xL23, H15mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732153691 FDA UDI
- 510(k) Number
- K192863 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Ceramic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Ceramic spinal interbody fusion cage
Mondrian Alif by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ceramic spinal interbody fusion cage.
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Cleared under the same submission
K192863 also covers:
- AL DISC PREP — CTL Medical Corporation
- AL Disc Prep — CTL Medical Corporation
- ALIF Disc Prep — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
- MONDRIAN — CTL Medical Corporation
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
- CTL Medical Corporation
Sources (1)
- FDA UDI 72d59f34-2084-4c2b-a317-f5c7fcb12cd9 35 fields · synced May 30, 2026