Identity
- Trade Name
- CEZANNE-II FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- CEZANNE-II DLIF Initial Distractor, 0° W19 x L60, H4mm, Short FDA UDI
- Model / Reference
- 104.7142 FDA UDI
- Description
- CEZANNE-II DLIF Initial Distractor, 0° W19 x L60, H4mm, Short FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732167247 FDA UDI
- 510(k) Number
- K131981 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, internal 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
No
FDA UDI
Implantable
No
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: Orthopaedic surgical distractor, internal
Cezanne-Ii by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131981 also covers:
- CEZANNE II — CTL Medical Corporation
- CEZANNE II — CTL Medical Corporation
- CEZANNE II — CTL Medical Corporation
- CEZANNE II — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — CTL Medical Corporation
- CEZANNE II Lumbar Interbody Fusion Cage System — 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 5f2fb5bf-dd5d-4ef3-802c-466c4265357e 35 fields · synced May 31, 2026