Identity
- Trade Name
- Matrixx System FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- Convexx Corpectomy, 12Dx14Wx27H, 6° FDA UDI
- Model / Reference
- 53A-1214-27-6-SP FDA UDI
- Description
- Convexx Corpectomy, 12Dx14Wx27H, 6° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889929059517 FDA UDI
- 510(k) Number
- K193412 FDA UDI
- FDA Product Code
- MQP FDA UDIPLR FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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 — 14 Millimeter FDA UDIHeight — 27 Millimeter FDA UDIDepth — 12 Millimeter FDA UDI
Category: Vertebral body prosthesis
Matrixx System by Nexxt Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vertebral body prosthesis.
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- VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- CASCADIA™ Interbody System — K2M, INC. · Class II
- CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
- Cascadia™ Interbody System — K2M, INC. · Class II
Cleared under the same submission
K193412 also covers:
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx System — NEXXT SPINE LLC
- Matrixx 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 51b80e1a-fd81-474a-aade-66b804173307 36 fields · synced Jun 1, 2026