Identity
- Trade Name
- VALEO FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Valeo TL Trial Full Size, 17mm FDA UDI
- Model / Reference
- 91.001.3517 FDA UDI
- Description
- Valeo TL Trial Full Size, 17mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732162679 FDA UDI
- 510(k) Number
- K091278 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Valeo by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General internal orthopaedic fixation system implantation kit.
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Cleared under the same submission
K091278 also covers:
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — CTL Medical Corporation
- VALEO — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CTL Medical Corporation
Sources (1)
- FDA UDI e73aa991-1132-4f26-ad00-ce655e1d82ac 34 fields · synced Jun 1, 2026