Identity
- Trade Name
- Tranquil-L Interbody System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- DLIF IBD 8x18x40, 6 deg FDA UDI
- Model / Reference
- 523377s FDA UDI
- Description
- DLIF IBD 8x18x40, 6 deg FDA UDI
Identifiers
- Primary DI / UDI-DI
- B678523377S0 FDA UDI
- 510(k) Number
- K233375 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
- 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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 18 Millimeter FDA UDILength — 40 Millimeter FDA UDIHeight — 8 Millimeter FDA UDI
Category: Metallic spinal interbody fusion cage
Tranquil-L Interbody System by Nexus Spine, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metallic spinal interbody fusion cage.
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Cleared under the same submission
K233375 also covers:
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
- Tranquil-L Interbody System — NEXUS SPINE, L.L.C.
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
- Nexus Spine, L.l.c.
Sources (1)
- FDA UDI 4b07a7a3-42fe-445c-9aa4-48c0fed28d0a 35 fields · synced Jun 1, 2026