Identity
- Trade Name
- NEXXT MATRIXX® Stand Alone ALIF System FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- SA ALIF, 30Dx40Wx20H 8° FDA UDI
- Model / Reference
- 61-3040-20-8-SP FDA UDI
- Description
- SA ALIF, 30Dx40Wx20H 8° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889929042519 FDA UDI
- 510(k) Number
- K202230 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
- 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 — 40 Millimeter FDA UDIDepth — 30 Millimeter FDA UDIAngle — 8 degree FDA UDIHeight — 20 Millimeter FDA UDI
Category: Metallic spinal interbody fusion cage
NEXXT MATRIXX® Stand Alone ALIF System by Nexxt Spine Llc — 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
K202230 also covers:
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone ALIF System — NEXXT SPINE LLC
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
- Nexxt Spine Llc
Sources (1)
- FDA UDI 0c9afd2f-b225-401b-b791-99a2bb0eb170 36 fields · synced May 30, 2026