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ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Interbody Fusion Device 24 Degree 50 (M/L) 18 (A/P) 19 mm FDA UDI
- Model / Reference
- 7124-0319-N FDA UDI
- Description
- Interbody Fusion Device 24 Degree 50 (M/L) 18 (A/P) 19 mm FDA UDI
Identifiers
- Catalog Number
- 7124-0319-N FDA UDI
- Primary DI / UDI-DI
- 00191375049203 FDA UDI
- FDA Product Code
- OVD 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIHeight — 19 Millimeter FDA UDIWidth — 18 Millimeter FDA UDIAngle — 24 degree FDA UDI
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 eaccb547-e52f-4053-bec7-b9c8f4c99326 37 fields · synced May 31, 2026