Identity
- Trade Name
- NEXXT MATRIXX® Stand Alone Cervical-TL System FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- SA Cervical-TL, Trial, 12x15x11mm FDA UDI
- Model / Reference
- I52N-TR25-11 FDA UDI
- Description
- SA Cervical-TL, Trial, 12x15x11mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889929036198 FDA UDI
- 510(k) Number
- K200543 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General internal orthopaedic fixation system implantation kit
NEXXT MATRIXX® Stand Alone Cervical-TL System by Nexxt Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
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- OsteoMed — Osteomed Corp. · Class II
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- CASCADIA™ Interbody System — K2M, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
Cleared under the same submission
K200543 also covers:
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL System — NEXXT SPINE LLC
- NEXXT MATRIXX® Stand Alone Cervical-TL 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 d1be6691-8aca-4b5d-bcef-b7da68476c82 35 fields · synced May 30, 2026