Identity
- Trade Name
- Endoskeleton TL FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Interbody Fusion Device 12 Degree 50 (M/L) 22 (A/P) 9 mm FDA UDI
- Model / Reference
- 7112-1309 FDA UDI
- Description
- Interbody Fusion Device 12 Degree 50 (M/L) 22 (A/P) 9 mm FDA UDI
Identifiers
- Catalog Number
- 7112-1309 FDA UDI
- Primary DI / UDI-DI
- M682711213090 FDA UDI
- 510(k) Number
- K140055 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
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
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIHeight — 9 Millimeter FDA UDIWidth — 22 Millimeter FDA UDIAngle — 12 degree FDA UDI
Endoskeleton TL by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140055 also covers:
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
- Titan Spine, Inc.
Sources (1)
- FDA UDI 7263a26a-1144-4d9f-9014-8dadaf3a2eb3 38 fields · synced May 31, 2026